Severe SepsisNCT01654003
Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery
A study testing OPTIMIZED in people with Severe Sepsis and Emergency, run by University Hospital, Geneva at 2 sites in Switzerland.
Trial summary
This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Emergency, Surgery
- What is being tested?
- OPTIMIZED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2010to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults > 18 years
- Severe sepsis* as defined by the ACCCP/SCCM consensus conference
- Need for emergent interventional procedure under general anesthesia with an expected duration > 120 min (in and out patients).
Who cannot join
- Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC
- Neurotrauma (Glasgow Coma Score < 12) and/ or medullar trauma
- Known pregnancy or diagnosed by US or Ct-scan (> 14 weeks)
- Sustained cardiac arrhythmia (see Logbook P8)
- Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8)
- Known or diagnosed intracardiac shunt: interventricular or atrial defect (see Logbook P8)
Show all 10Show fewer
- Burn injury > 10%
- Needed emergency thoracotomy or ABC resuscitation protocol
- Pre-existing severe liver dysfunction(Child-Pugh class C)
- Do-not-resuscitate order, died within 48h of admission
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, 12011
Emergency operating room, Geneva Cantonal Hospital
Geneva, Canton of Geneva, 1211
About this study
Official title: Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery. A Prospective, Randomised, Open Trial
This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.
- Conditions
- Severe Sepsis, Emergency, Surgery
- Being tested
- CONTROL, OPTIMIZED
- Keywords
- Goal-directed therapy, severe sepsis, emergency surgery, vasopressor, dynamic flow-related parameters
- Medical subject headings
- Sepsis, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONTROLOther
Also called standard care, fluide therapy, vasopressor, sepsis
In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.
OPTIMIZEDOther
Also called GDT fluide therapy, Picco
In the OPTIMIZED group, the haemodynamic monitor (Pulsiocath)will help to a goal-directed administration of fluid (250-500ml crystalloids or colloids).The cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI).
| Study group | Role | What they receive |
|---|---|---|
| CONTROL | Active comparator | In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.
At the discretion of the attending anaesthesiologist with the FMH level, a pulmonary artery catheter, a transoesophageal Doppler flow probe or the PiCCO monitor will be inserted to complement the standard hemodynamic monitoring if deemed necessary. Receives: Other: CONTROL |
| OPTIMIZED | Active comparator | In the OPTIMIZED group, the central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany).
The administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI). Receives: Other: OPTIMIZED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta lactate
The primary study endpoint will be the difference between the baseline arterial blood lactate at the time of randomization and the value of the arterial blood lactate at the time of transfer from the emergency operating room (∆ lactate).
Measured: From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours.
Secondary outcomes (14)
Cardiovascular complications: myocardial infarct or congestive heart failure
Clinical outcome and surrogate biomarkers (Troponin-I and pro-BNP: day 1-2-3) will be recorded by extracting this specific data from the electronic medical file, until discharge, death or up to 28 days, whichever comes first.
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Cerebral complications: stroke
Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Pulmonary complications: ALI/ARDS, bronchopneumonia
Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Pulmonary complications: respiratory insufficiency necessitating re-intubation
Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Surgical complications: re-operation for bleeding or infection
Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Renal complications: infection, urosepsis or renal insufficiency
Clinical outcome and surrogate biomarkers (Riffle score, creatinine: day 1-2-3) will be recorded by extracting this specific data from the electronic medical file, until discharge, death or up to 28 days, whichever comes first.
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Duration of post-operative mechanical ventilation: in hours
Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Total duration of ventilation : days
Clinical outcomes (ventilation free days) will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Length of stay in the ICU: in days
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Length of stay in hospital: in days
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Mortality
Measured: From randomization up to 28 days
SOFA score measurement
Measured: From randomization : day 1, day 2, day 3
Death
Measured: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Number of unexpected ICU admission
Measured: From randomization up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startApr 2010
- Primary completionJun 2014
- Study completionDec 2014
Why it stopped: recrutment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavlovic Gordana, MD, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654003
- Sponsor's protocol ID
- NAC 09-044 B
- Status last verified
- May 2016
- First submitted
- 18 Jul 2012
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery. A Prospective, Randomised, Open Trial
- ClinicalTrials.gov ID
- NCT01654003
- Acronym / sponsor ID
- NAC 09-044 B
- Conditions
- Severe Sepsis, Emergency, Surgery
- Keywords
- Goal-directed therapy, severe sepsis, emergency surgery, vasopressor, dynamic flow-related parameters
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recrutment difficulties
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Jul 2012 (estimated)
- 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 study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL | Active comparator | Other: CONTROLIn the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg. At the discretion of the attending anaesthesiologist with the FMH level, a pulmonary artery catheter, a transoesophageal Doppler flow probe or the PiCCO monitor will be inserted to complement the standard hemodynamic monitoring if deemed necessary. |
| OPTIMIZED | Active comparator | Other: OPTIMIZEDIn the OPTIMIZED group, the central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany). The administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults > 18 years
- Severe sepsis* as defined by the ACCCP/SCCM consensus conference
- Need for emergent interventional procedure under general anesthesia with an expected duration > 120 min (in and out patients).
Key exclusion criteria (10 listed)
- Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC
- Neurotrauma (Glasgow Coma Score < 12) and/ or medullar trauma
- Known pregnancy or diagnosed by US or Ct-scan (> 14 weeks)
- Sustained cardiac arrhythmia (see Logbook P8)
- Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8)
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 |
|---|---|---|
| CONTROLAlso: standard care, fluide therapy, vasopressor, sepsisIn the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg. | Other | CONTROL |
| OPTIMIZEDAlso: GDT fluide therapy, PiccoIn the OPTIMIZED group, the haemodynamic monitor (Pulsiocath)will help to a goal-directed administration of fluid (250-500ml crystalloids or colloids).The cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI). | Other | OPTIMIZED |
Primary outcome
Delta lactate
Time frame: From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours.
The primary study endpoint will be the difference between the baseline arterial blood lactate at the time of randomization and the value of the arterial blood lactate at the time of transfer from the emergency operating room (∆ lactate).
14 secondary outcomes
Cardiovascular complications: myocardial infarct or congestive heart failure
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Cerebral complications: stroke
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Pulmonary complications: ALI/ARDS, bronchopneumonia
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Pulmonary complications: respiratory insufficiency necessitating re-intubation
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Surgical complications: re-operation for bleeding or infection
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Renal complications: infection, urosepsis or renal insufficiency
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Duration of post-operative mechanical ventilation: in hours
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Total duration of ventilation : days
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Length of stay in the ICU: in days
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Length of stay in hospital: in days
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.
Mortality
Time frame: From randomization up to 28 days
SOFA score measurement
Time frame: From randomization : day 1, day 2, day 3
Death
Time frame: Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first
Number of unexpected ICU admission
Time frame: From randomization up to 28 days
Results and safety
The study was stopped early (reason given: recrutment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMIZED in people with Severe Sepsis and Emergency, run by University Hospital, Geneva at 2 sites in Switzerland.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
The study was stopped early (reason given: recrutment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta lactate (time frame: From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2016.