Septic ShockNCT04728529
Septic Shock Management Guided by Ultrasound: SEPTICUS Trial
A study testing USSM protocol and ACCM protocol in people with Septic Shock, run by Saptadi Yuliarto at 1 site in Indonesia.
Trial summary
This clinical study aims to compare the recent septic shock management protocol from American College of Critical Care Medicine (ACCM) to Ultrasound-guided Septic Shock Management (USSM) protocol. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- USSM protocol and ACCM protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Sep 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosed as septic shock according to Pediatric Surviving Campaign (2005)
Who cannot join
- patient with uncorrected congenital heart disease with shunting
- obtain fluid resuscitation before recruitment process
- obtain inotropic-vasoactive agent before recruitment process
- after undergo any heart surgery
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSUD dr. Saiful Anwar
Malang, East Java, 65145
Saptadi Yuliarto, MD, +6281233053652, saptadiy@ub.ac.id
Kurniawan Taufiq Kadafi, MD
About this study
Official title: Septic Shock Management Guided by Ultrasound: A Randomized Control Trial (SEPTICUS Trial)
This clinical study aims to compare the recent septic shock management protocol from American College of Critical Care Medicine (ACCM) to Ultrasound-guided Septic Shock Management (USSM) protocol. USSM protocol laid on Doppler ultrasonography to evaluate stroke volume, cardiac index, and systemic vascular resistance in each step of management to decide the proper fluid resuscitation and vasoactive therapy; differs from ACCM protocol which use clinical finding in its early step. ACCM protocol application elicits risk of improper therapy since clinical sign per se often could not describe the certain cardiac output. This can be prevented earlier by USSM protocol. The outcome compared of the two protocols is: mortality rate, clinical parameter, macrocirculation hemodynamic parameter, laboratory microcirculation parameter, and signs of fluid overload. The investigators hypothesized if the USSM protocol had a better outcome and less fluid overload complication.
Read the detailed description
This study is a randomized controlled trial to compare the usage of ACCM protocol and USSM protocol in fluid resuscitation for septic shock pediatric patients. The USSM protocol is the intervention, and the ACCM protocol is the control. This study implemented in septic shock pediatric patients treated in the intensive care unit. Each patient will be randomized into 2 groups, the USSM group or the ACCM group. In the initial step, all patient in each group will receive early acute/emergency therapy: oxygen support, vascular access, and fluid resuscitation. The monitoring of the patient including clinical parameters and laboratory examination for both groups, except Doppler ultrasonography that performed in each step of management of the intervention group. The monitoring is performed every 15 minutes in the first hour of resuscitation. If the patient show good response (fluid responsive shock), the monitoring stops in 1 hour. In contrast, if the patient reveal fluid refractory shock, the vasoactive agent will be administered and monitoring continues until 6 hours. All outcome parameters, except mortality rate, will be recorded at 6 hours. The mortality rates will be recorded at 72 hours and time of intensive care discharge.
Sample size in this study was calculated by clinical trial formula for mortality rate with a significance level of 0.05 and study power of 0.2. From the calculation, the subject needed is 170 patients for each group (total 340 subjects). The basic characteristics of the patient will be analyzed descriptively. All parameter data will be analyzed statistically by Statistical Product and Service Solution (SPSS) 20, preceded by normality test and homogeneity test. The study analysis will be intention-to-treat. The mortality rate was analyzed by Kaplan-Meier survival analysis. Data transformation will be performed if needed in case of outlier data or out-of-range results.
- Conditions
- Septic Shock
- Being tested
- USSM protocol, ACCM protocol
- Keywords
- septic shock, Doppler ultrasonography, Fluid resuscitation, Vasoactive therapy, Mortality rate, Fluid overload
- Medical subject headings
- Shock, Septic, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USSM protocolProcedure or surgery
In the initial step, all subjects will receive emergency management: oxygen support, vascular access, and fluid therapy. Doppler ultrasonography by Ultrasound Cardiac Output Monitoring (USCOM) is also performed to record initial stroke volume (SV), cardiac index (CI), and systemic vascular resistance (SVR). The initial fluid resuscitation is 20 mL/kg body weight, then the response measured by clinical and USCOM examination. If any improvement of clinical sign and normal SVI, CI, SVR, intervention will be stopped. In contrary, if shock persist, subsequent fluid resuscitation and/or vasoactive therapy will be administered, guided by USCOM.
The therapeutic goal of USCOM: SVI 30-60 mL/m2, CI 3.3-6.0 L/minute/m2, and SVRI 800-1600 d.s/cm5/m2
ACCM protocolProcedure or surgery
In the initial step, all subjects will receive emergency management: oxygen support, vascular access, and fluid therapy. Doppler ultrasonography by Ultrasound Cardiac Output Monitoring (USCOM) is also performed to record initial stroke volume (SV), cardiac index (CI), and systemic vascular resistance (SVR). The initial fluid resuscitation is 20 mL/kg body weight, then the response measured by clinical. If any improvement of clinical sign, intervention will be stopped. In contrary, if shock persist, subsequent fluid resuscitation and/or vasoactive therapy will be administered, guided by clinical parameter.
| Study group | Role | What they receive |
|---|---|---|
| USSM protocol | Experimental | patient in the intervention group receive fluid resuscitation and inotropic-vasoactive agent, if needed, in accordance to USSM protocol of fluid resuscitation. Receives: Procedure: USSM protocol |
| ACCM protocol | Experimental | patient in the control group receive fluid resuscitation and inotropic-vasoactive agent, if needed, in accordance to ACCM protocol of fluid resuscitation. Receives: Procedure: ACCM protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Time of mortality occurrence since randomization, comparing intervention and control group.
Measured: 72 hours of the initial fluid resuscitation
Number of mortality
Amount of non-survivor subject, comparing intervention and control group.
Measured: 72 hours of the initial fluid resuscitation
Secondary outcomes (13)
Heart rate
Heart rate is measured by vital sign monitor device, reported in beat/minute, and classified into bradycardia (below normal rate according to age of PALS criteria), normal, and tachycardia (above normal rate according to age of PALS criteria).
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Capillary refill time
Capillary refill time is measured by pressing forehead and sternal skin; time needed for the pink color to return will be measured and reported in second, then classified based on WHO criteria, into prolonged (above 3 seconds) or normal (below or equal than 3 seconds).
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Peripheral pulse strength
Peripheral pulse strength is measured by comparing peripheral radial pulse and central (carotid or femoral) pulse, reported qualitatively as weak or normal/strong
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Systolic blood pressure
Systolic blood pressure is measured by vital sign monitor device and reported in mmHg, and classified into hypotension (below 5th percentiles according to age of PALS criteria), normal (above or equal than 5th percentiles according to age of PALS criteria), and high (above 95th percentiles according to age of PALS criteria).
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Mean arterial pressure
Mean arterial pressure (MAP) is measured by vital sign monitor device and reported in mmHg, and classified into hypotension (below 5th percentiles according to age of PALS criteria), normal (above or equal than 5th percentiles according to age of PALS criteria), and high (above 95th percentiles according to age of PALS criteria).
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Systemic vascular resistance index
Systemic vascular resistance index (SVRI) is measured by USCOM, reported in d.s/cm5/m2, and classified into low (below 800), normal (800 to 1600), and high (above 1600)
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Stroke volume index
Stroke volume index (SVI) is measured by USCOM, reported in mL/m2, and classified into low (below 30), normal (30 to 60), and high (above 60).
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Cardiac index
Cardiac index (CI) is measured by USCOM, reported in L/minute/m2, and classified into low (below 3.3), normal (3.3 to 6.0), and high (above 6.0).
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Base deficit
Base deficit is measured by blood gas analysis examination, reported in mmol/L, and classified into low (below -3), normal (-3 to 3), and high (above 3).
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Blood lactate level
Blood lactate level is measured from arterial blood, reported in mmol/L, and classified into normal (below or equal to 2.0) or high (above 2.0).
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Liver span increase
The increase of liver span is clinically measured from mid-costal right arch to the edge of liver, and reported in centimeters.
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Lung ultrasound score
Lung Ultrasound Score is examined with ultrasound using linear transducer (7.5 to 11 Mhz) to measure pulmonary parenchyma aeration on 12 scan areas (6 areas in each hemithorax), by a doctor who is ultrasound-certified lung. Each hemithorax is divided by 3 vertical lines (parasternal, anterior axillary, and posterior axillary) so that it becomes 3 areas (anterior, lateral, and posterior); and 1 horizontal line dividing the hemithorax into 2 equal parts. In each area a score is recorded. The final result is a total score of 12 areas. The scores are stated as follows:
- 0 = no (or very few) B-lines ii. 1 = B-lines look many but separate (separated B-lines) iii. 2 = many B-lines and converge (coalescent B-lines) iv. 3 = lung consolidation
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Vasoactive-inotropic score (VIS)
The Vasoactive-Inotropic Score (VIS), quantifies the amount of cardiovascular support required by subjects and includes dopamine, dobutamine, epinephrine, milrinone, vasopressin, and norepinephrine.
Measured: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start2 Sep 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Each eligible patient will be randomized into 2 groups of treatment, the USSM protocol or the ACCM protocol. All of subjects in each group will receive emergency management: oxygen support, vascular access, and fluid resuscitation. In intervention group, each step of fluid and vasoactive management will be guided by clinical sign and Doppler ultrasonography, whereas in control group only guided by the clinical sign.
- Masking
- None (open label)
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saptadi Yuliarto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Saptadi Yuliarto, University of Brawijaya
- Investigators
- Saptadi Yuliarto, MD, Study director, University of Brawijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728529
- Sponsor's protocol ID
- University of Brawijaya
- Status last verified
- Sep 2021
- First submitted
- 31 Dec 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Davis AL, Carcillo JA, Aneja RK, Deymann AJ, Lin JC, Nguyen TC, Okhuysen-Cawley RS, Relvas MS, Rozenfeld RA, Skippen PW, Stojadinovic BJ, Williams EA, Yeh TS, Balamuth F, Brierley J, de Caen AR, Cheifetz IM, Choong K, Conway E Jr, Cornell T, Doctor A, Dugas MA, Feldman JD, Fitzgerald JC, Flori HR, Fortenberry JD, Graciano AL, Greenwald BM, Hall MW, Han YY, Hernan LJ, Irazuzta JE, Iselin E, van der Jagt EW, Jeffries HE, Kache S, Katyal C, Kissoon N, Kon AA, Kutko MC, MacLaren G, Maul T, Mehta R, Odetola F, Parbuoni K, Paul R, Peters MJ, Ranjit S, Reuter-Rice KE, Schnitzler EJ, Scott HF, Torres A Jr, Weingarten-Arams J, Weiss SL, Zimmerman JJ, Zuckerberg AL. American College of Critical Care Medicine Clinical Practice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock. Crit Care Med. 2017 Jun;45(6):1061-1093. doi: 10.1097/CCM.0000000000002425.
PubMed 28509730Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children. Pediatr Crit Care Med. 2020 Feb;21(2):e52-e106. doi: 10.1097/PCC.0000000000002198.
PubMed 32032273Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children. Intensive Care Med. 2020 Feb;46(Suppl 1):10-67. doi: 10.1007/s00134-019-05878-6.
PubMed 32030529Santhanam I, Sangareddi S, Venkataraman S, Kissoon N, Thiruvengadamudayan V, Kasthuri RK. A prospective randomized controlled study of two fluid regimens in the initial management of septic shock in the emergency department. Pediatr Emerg Care. 2008 Oct;24(10):647-55. doi: 10.1097/PEC.0b013e31818844cf.
PubMed 19242131Ranjit S, Aram G, Kissoon N, Ali MK, Natraj R, Shresti S, Jayakumar I, Gandhi D. Multimodal monitoring for hemodynamic categorization and management of pediatric septic shock: a pilot observational study*. Pediatr Crit Care Med. 2014 Jan;15(1):e17-26. doi: 10.1097/PCC.0b013e3182a5589c.
PubMed 24196006Ceneviva G, Paschall JA, Maffei F, Carcillo JA. Hemodynamic support in fluid-refractory pediatric septic shock. Pediatrics. 1998 Aug;102(2):e19. doi: 10.1542/peds.102.2.e19.
PubMed 9685464Horster S, Stemmler HJ, Strecker N, Brettner F, Hausmann A, Cnossen J, Parhofer KG, Nickel T, Geiger S. Cardiac Output Measurements in Septic Patients: Comparing the Accuracy of USCOM to PiCCO. Crit Care Res Pract. 2012;2012:270631. doi: 10.1155/2012/270631. Epub 2011 Nov 29.
PubMed 22191019Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.
PubMed 15636651
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Septic Shock Management Guided by Ultrasound: A Randomized Control Trial (SEPTICUS Trial)
- ClinicalTrials.gov ID
- NCT04728529
- Acronym / sponsor ID
- University of Brawijaya
- Conditions
- Septic Shock
- Keywords
- septic shock, Doppler ultrasonography, Fluid resuscitation, Vasoactive therapy, Mortality rate, Fluid overload
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Saptadi YuliartoUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study aims to compare the recent septic shock management protocol from American College of Critical Care Medicine (ACCM) to Ultrasound-guided Septic Shock Management (USSM) protocol. USSM protocol laid on Doppler ultrasonography to evaluate stroke volume, cardiac index, and systemic vascular resistance in each step of management to decide the proper fluid resuscitation and vasoactive therapy; differs from ACCM protocol which use clinical finding in its early step. ACCM protocol application elicits risk of improper therapy since clinical sign per se often could not describe the certain cardiac output. This can be prevented earlier by USSM protocol. The outcome compared of the two protocols is: mortality rate, clinical parameter, macrocirculation hemodynamic parameter, laboratory microcirculation parameter, and signs of fluid overload. The investigators hypothesized if the USSM protocol had a better outcome and less fluid overload complication.
Detailed description
This study is a randomized controlled trial to compare the usage of ACCM protocol and USSM protocol in fluid resuscitation for septic shock pediatric patients. The USSM protocol is the intervention, and the ACCM protocol is the control. This study implemented in septic shock pediatric patients treated in the intensive care unit. Each patient will be randomized into 2 groups, the USSM group or the ACCM group. In the initial step, all patient in each group will receive early acute/emergency therapy: oxygen support, vascular access, and fluid resuscitation. The monitoring of the patient including clinical parameters and laboratory examination for both groups, except Doppler ultrasonography that performed in each step of management of the intervention group. The monitoring is performed every 15 minutes in the first hour of resuscitation. If the patient show good response (fluid responsive shock), the monitoring stops in 1 hour. In contrast, if the patient reveal fluid refractory shock, the vasoactive agent will be administered and monitoring continues until 6 hours. All outcome parameters, except mortality rate, will be recorded at 6 hours. The mortality rates will be recorded at 72 hours and time of intensive care discharge.
Sample size in this study was calculated by clinical trial formula for mortality rate with a significance level of 0.05 and study power of 0.2. From the calculation, the subject needed is 170 patients for each group (total 340 subjects). The basic characteristics of the patient will be analyzed descriptively. All parameter data will be analyzed statistically by Statistical Product and Service Solution (SPSS) 20, preceded by normality test and homogeneity test. The study analysis will be intention-to-treat. The mortality rate was analyzed by Kaplan-Meier survival analysis. Data transformation will be performed if needed in case of outlier data or out-of-range results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each eligible patient will be randomized into 2 groups of treatment, the USSM protocol or the ACCM protocol. All of subjects in each group will receive emergency management: oxygen support, vascular access, and fluid resuscitation. In intervention group, each step of fluid and vasoactive management will be guided by clinical sign and Doppler ultrasonography, whereas in control group only guided by the clinical sign.
| Arm | Type | Receives |
|---|---|---|
| USSM protocol | Experimental | Procedure: USSM protocolpatient in the intervention group receive fluid resuscitation and inotropic-vasoactive agent, if needed, in accordance to USSM protocol of fluid resuscitation. |
| ACCM protocol | Experimental | Procedure: ACCM protocolpatient in the control group receive fluid resuscitation and inotropic-vasoactive agent, if needed, in accordance to ACCM protocol of fluid resuscitation. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- diagnosed as septic shock according to Pediatric Surviving Campaign (2005)
Key exclusion criteria (4 listed)
- patient with uncorrected congenital heart disease with shunting
- obtain fluid resuscitation before recruitment process
- obtain inotropic-vasoactive agent before recruitment process
- after undergo any heart surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USSM protocolIn the initial step, all subjects will receive emergency management: oxygen support, vascular access, and fluid therapy. Doppler ultrasonography by Ultrasound Cardiac Output Monitoring (USCOM) is also performed to record initial stroke volume (SV), cardiac index (CI), and systemic vascular resistance (SVR). The initial fluid resuscitation is 20 mL/kg body weight, then the response measured by clinical and USCOM examination. If any improvement of clinical sign and normal SVI, CI, SVR, intervention will be stopped. In contrary, if shock persist, subsequent fluid resuscitation and/or vasoactive therapy will be administered, guided by USCOM. The therapeutic goal of USCOM: SVI 30-60 mL/m2, CI 3.3-6.0 L/minute/m2, and SVRI 800-1600 d.s/cm5/m2 | Procedure or surgery | USSM protocol |
| ACCM protocolIn the initial step, all subjects will receive emergency management: oxygen support, vascular access, and fluid therapy. Doppler ultrasonography by Ultrasound Cardiac Output Monitoring (USCOM) is also performed to record initial stroke volume (SV), cardiac index (CI), and systemic vascular resistance (SVR). The initial fluid resuscitation is 20 mL/kg body weight, then the response measured by clinical. If any improvement of clinical sign, intervention will be stopped. In contrary, if shock persist, subsequent fluid resuscitation and/or vasoactive therapy will be administered, guided by clinical parameter. | Procedure or surgery | ACCM protocol |
Primary outcome
Mortality rate
Time frame: 72 hours of the initial fluid resuscitation
Time of mortality occurrence since randomization, comparing intervention and control group.
Number of mortality
Time frame: 72 hours of the initial fluid resuscitation
Amount of non-survivor subject, comparing intervention and control group.
13 secondary outcomes
Heart rate
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Capillary refill time
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Peripheral pulse strength
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Systolic blood pressure
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Mean arterial pressure
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Systemic vascular resistance index
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Stroke volume index
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Cardiac index
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Base deficit
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Blood lactate level
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Liver span increase
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Lung ultrasound score
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Vasoactive-inotropic score (VIS)
Time frame: 1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 28509730Davis AL, Carcillo JA, Aneja RK, Deymann AJ, Lin JC, Nguyen TC, Okhuysen-Cawley RS, Relvas MS, Rozenfeld RA, Skippen PW, Stojadinovic BJ, Williams EA, Yeh TS, Balamuth F, Brierley J, de Caen AR, Cheifetz IM, Choong K, Conway E Jr, Cornell T, Doctor A, Dugas MA, Feldman JD, Fitzgerald JC, Flori HR, Fortenberry JD, Graciano AL, Greenwald BM, Hall MW, Han YY, Hernan LJ, Irazuzta JE, Iselin E, van der Jagt EW, Jeffries HE, Kache S, Katyal C, Kissoon N, Kon AA, Kutko MC, MacLaren G, Maul T, Mehta R, Odetola F, Parbuoni K, Paul R, Peters MJ, Ranjit S, Reuter-Rice KE, Schnitzler EJ, Scott HF, Torres A Jr, Weingarten-Arams J, Weiss SL, Zimmerman JJ, Zuckerberg AL. American College of Critical Care Medicine Clinical Practice Parameters for Hemodynamic Support of Pediatric and Neonatal Septic Shock. Crit Care Med. 2017 Jun;45(6):1061-1093. doi: 10.1097/CCM.0000000000002425.
- Background: PubMed 32032273Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children. Pediatr Crit Care Med. 2020 Feb;21(2):e52-e106. doi: 10.1097/PCC.0000000000002198.
- Background: PubMed 32030529Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving sepsis campaign international guidelines for the management of septic shock and sepsis-associated organ dysfunction in children. Intensive Care Med. 2020 Feb;46(Suppl 1):10-67. doi: 10.1007/s00134-019-05878-6.
- Background: PubMed 19242131Santhanam I, Sangareddi S, Venkataraman S, Kissoon N, Thiruvengadamudayan V, Kasthuri RK. A prospective randomized controlled study of two fluid regimens in the initial management of septic shock in the emergency department. Pediatr Emerg Care. 2008 Oct;24(10):647-55. doi: 10.1097/PEC.0b013e31818844cf.
- Background: PubMed 24196006Ranjit S, Aram G, Kissoon N, Ali MK, Natraj R, Shresti S, Jayakumar I, Gandhi D. Multimodal monitoring for hemodynamic categorization and management of pediatric septic shock: a pilot observational study*. Pediatr Crit Care Med. 2014 Jan;15(1):e17-26. doi: 10.1097/PCC.0b013e3182a5589c.
- Background: PubMed 9685464Ceneviva G, Paschall JA, Maffei F, Carcillo JA. Hemodynamic support in fluid-refractory pediatric septic shock. Pediatrics. 1998 Aug;102(2):e19. doi: 10.1542/peds.102.2.e19.
- Background: PubMed 22191019Horster S, Stemmler HJ, Strecker N, Brettner F, Hausmann A, Cnossen J, Parhofer KG, Nickel T, Geiger S. Cardiac Output Measurements in Septic Patients: Comparing the Accuracy of USCOM to PiCCO. Crit Care Res Pract. 2012;2012:270631. doi: 10.1155/2012/270631. Epub 2011 Nov 29.
- Background: PubMed 15636651Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saptadi Yuliarto, MD study director
University of Brawijaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing USSM protocol and ACCM protocol in people with Septic Shock, run by Saptadi Yuliarto at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saptadi Yuliarto, MD (+6281233053652, saptadiy@ub.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 72 hours of the initial fluid resuscitation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04728529, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.