Goal-Directed Fluid TherapyNCT04265014
Comparison of Goal-directed and Liberal Fluid Management
A study testing Goal-directed fluid treatment and Liberal Fluid Therapy in people with Goal-Directed Fluid Therapy and Hemodynamic Monitoring, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Background: The investigators aim is to indicate that the "goal directed fluid management" is more effective for open abdominal surgeries by performing perioperative hemodynamic monitorisation using a minimal invasive pulse counter analysis method. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Goal-Directed Fluid Therapy, Hemodynamic Monitoring, Fluid Management
- What is being tested?
- Goal-directed fluid treatment and Liberal Fluid Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 Jul 2020
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with major abdominal surgery
- ASA risk classification II-III
Who cannot join
- Peripheral artery disease
- Not in sinus rhythm
- Peroperative major hemorrhage (more than 500 mL hemorrhage within 1 hour)
- Pregnant or breastfeeding
- Advanced degree of liver and renal failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırkoy Sadi Konuk Training and Research Hospital
Istanbul
About this study
Official title: Comparison of Goal-directed and Liberal Fluid Management With Minimal Invasive Hemodynamic Monitoring in Abdominal Surgeries: A Randomized Prospective Study
Background: The investigators aim is to indicate that the "goal directed fluid management" is more effective for open abdominal surgeries by performing perioperative hemodynamic monitorisation using a minimal invasive pulse counter analysis method.
Methods: The study will be included 90 participants with ASA II-III risk score aged from 18-64 years. The prospective and randomized participants will be divided into 2 groups as liberal (Group L) and goal-directed fluid therapy (Group G) fluid treatment. Hemodynamic parameters and arterial blood gas analysis will be recorded at 30 min intervals. Preoperative and postoperative creatinine values, CR-POSSUM physiological score, Charlson comorbidity index (CCI), perioperative and postoperative vasopressor use, postoperative acute kidney injury network (AKIN), postoperative intensive care requirements, duration of hospital stay and 30-day mortality will be recorded.
Read the detailed description
Blood will be taken and assessed from the participants preoperatively one day before surgery and creatinine, neutrophil, lymphocyte and neutrophil / lymphocyte values will be recorded.
Though the gastrointestinal surgery team is the same, randomization will not be applied for the primary operating surgeon and primary surgeon selection will not be performed. Participants in both groups will have age, gender, height, weight, body mass index (BMI), comorbidities, CCI, POSSUM physiologic score and ASA risk score recorded. After being taken to the operation room, standard monitoring (ECG, SO2, NIBP) will be performed. A peripheral venous route will be opened with an 18-gauge needle. Participants will be began 5 mL/kg/hr crystalloid (isolyte) infusion as standard. Later participants who accept will have an epidural catheter inserted at the thoracic 10-11 level. After ensuring hemodynamic stabilization in both groups, sedation will be provided with 0.03 mg/kg midazolam and arterial monitoring will be provided with radial artery cannulation with a 20-gauge peripheral cannula.
Induction and General Anesthesia Management:
For induction 1-2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used, and participants will be orotracheally intubated after two minute ventilation. A MAQUET flow-I anesthesia device will be placed in volume control (VC) mode by setting to 8 mL/kg tidal volume and 12/min respiratory count according to ideal body weight with PetCO2 35-45 mmHg. Later, central venous catheterization will be performed on the right internal jugular vein using USG guidance. Sevoflurane (MAC 0.7-0.9) and remifentanil infusion (0.05-0.3 mcg/kg/min) will be used in anesthesia maintenance.
Monitoring:
After radial artery and central jugular vein catheterization in Group G, they will be linked to an EV1000 Flo-trac monitor and monitoring provided continuous mean arterial pressure (MAP) monitoring with heart rate (HR), stroke volume variation (SVV), central venous pressure (CVP), systemic vascular resistance index (SVRI) and cardiac index (CI) measured every minute. After monitoring blood gas will be taken and the initial value accepted as time-1 (t1). At 5 minute intervals, mean arterial pressure (MAP), momentary heart rate (HR) will be recorded, with CVP, CI, SVV, and SVRI recorded at 30 minute intervals for a total of 240 minutes (t1, t2, t3, t4, t5, t6, t7, t8, t9), urine amount and blood gas values (pH, PCO2, PO2, bicarbonate (HCO3), base minus (BM), lactate (lac), hemoglobin (Hb), hematocrit (Ht)) will also be recorded.
In Group L, radial arterial cannulation and central jugular venous catheterization will be performed with the first value during monitoring accepted as t1. Then HR and MPA will be recorded at 5-minute intervals, CVP at 30 minute intervals for a total of 240 minutes (t1, t2, t3, t4, t5, t6, t7, t8, t9) and urine amount and blood gas values (pH, PCO2, PO2, HCO3, BM, lac, Hb, Ht) will also be recorded.
Peroperative fluid management:
- Group G: Fluid management will be performed according to SVV and CI monitoring. When participants have SVV>10%, 250 cc crystalloid will be administered and when SVV fell below 10% during 30-minute monitoring standard (5 mL/kg/hr) crystalloid infusion continues. If SVV continues above 10%, a second fluid bolus of 250 cc colloid (minifluid challenge) will be administered. If the desired SVV level can not be reached, the Hct values will be examined. Blood replacement will be performed when Hct<30% in participants with coronary artery disease (CAD) and when Hct<25% for other groups. If the desired SVV level can not be reached in spite of blood replacement products, if CI will be below 2.5 L/min/m2 vasopressor will begun. If SVV will be at normal values with CI below 2.5 L/min/m2, inotrop will begun.
- Group L:
Fluid management will be performed according to MAP, HR and urine output. If peroperative urine amounts will be <0.5 mL/kg/hr during two-hour monitoring, with MAP<65 mmHg, HR>100/min for at least 30 minutes and CVP falls 20% compared to basal values, the same anesthesiologist will begin additional fluid replacement of 5 mL/kg/hr based on clinical experience. Blood product replacement will be provided at Hct<30% for those with coronary artery disease and at Hct<25% for other participants.
The operation durations, administered fluid types, fluid amounts and blood product amounts will be recorded. Participants having intensive care need preoperatively planned intensive care will have planned admission, while participants developing hemodynamic instability linked to peroperative surgery or anesthesia will be admitted as unplanned care. All participants will have creatinine, neutrophil, lymphocyte and neutrophil/lymphocyte values recorded in the 1st and 24th hours postoperative and participants with fever (>38 °C) in the 1st day will be recorded. Acute kidney injury network (AKIN) classification will be made according to creatinine values measured preoperatively and on the postoperative 1st day. In the postoperative 30-day period, duration of hospital stay, surgical and pulmonary complications, inotrop or vasopressor requirements, reason for admission to intensive care, and duration of stay in intensive care if required will be recorded.
- Being tested
- Goal-directed fluid treatment, Liberal Fluid Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed fluid treatmentOther
Goal-directed fluid treatment for major abdominal surgery
Liberal Fluid TherapyOther
Liberal Fluid Therapy for major abdominal surgery
| Study group | Role | What they receive |
|---|---|---|
| Goal-directed fluid treatment | Active comparator | Fluid management will be performed according to SVV and CI monitoring. When patients have SVV>10%, 250 cc crystalloid will be administered and when SVV fell below 10% during 30-minute monitoring standard (5 mL/kg/hr) crystalloid infusion continues. If SVV continues above 10%, a second fluid bolus of 250 cc colloid (minifluid challenge) will be administered.
If the desired SVV level can not be reached, the Hct values will be examined. Blood replacement will be performed when Hct<30% in patients with coronary artery disease (CAD) and when Hct<25% for other patient groups. If the desired SVV level can not be reached in spite of blood replacement products, if CI will be below 2.5 L/min/m2 vasopressor will begun. If SVV will be at normal values with CI below 2.5 L/min/m2, inotrop will begun. Receives: Other: Goal-directed fluid treatment |
| liberal fluid treatment | Active comparator | Fluid management will be performed according to MAP, HR and urine output.
If peroperative urine amounts will be <0.5 mL/kg/hr during two-hour monitoring, with MAP<65 mmHg, HR>100/min for at least 30 minutes and CVP falls 20% compared to basal values, the same anesthesiologist will begin additional fluid replacement of 5 mL/kg/hr based on clinical experience.
Blood product replacement will be provided at Hct<30% for those with coronary artery disease and at Hct<25% for other patients. Receives: Other: Liberal Fluid Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peroperative Hemodiynamic, Mean Arterial Pressure
Mean arterial pressure (mmHg)
Measured: During the surgery
Peroperative Hemodiynamic, Kidney Function
Urine output (ml/h)
Measured: During the surgery
Peroperative Hemodiynamic, Pulse
Heart rate (beats per minute)
Measured: During the surgery
Peroperative Hemodiynamic, Fluid response
Stroke Volume Variation (%)
Measured: During the surgery
Peroperative Hemodiynamic, Cardiac output
Cardiac Index (l/min/m2)
Measured: During the surgery
Secondary outcomes (1)
Number of Participants
The study will be terminated when a total of 90 patients are reached.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jan 2020
- Primary completion1 May 2020
- Study completion1 Jul 2020
Why it stopped: we didn't have any patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Goal-Directed Fluid TherapyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265014
- Sponsor's protocol ID
- 165/2017
- Status last verified
- Jul 2020
- First submitted
- 28 Jan 2020
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Goal-directed and Liberal Fluid Management With Minimal Invasive Hemodynamic Monitoring in Abdominal Surgeries: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04265014
- Acronym / sponsor ID
- 165/2017
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: we didn't have any patient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 11 Feb 2020 (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.
Background: The investigators aim is to indicate that the "goal directed fluid management" is more effective for open abdominal surgeries by performing perioperative hemodynamic monitorisation using a minimal invasive pulse counter analysis method.
Methods: The study will be included 90 participants with ASA II-III risk score aged from 18-64 years. The prospective and randomized participants will be divided into 2 groups as liberal (Group L) and goal-directed fluid therapy (Group G) fluid treatment. Hemodynamic parameters and arterial blood gas analysis will be recorded at 30 min intervals. Preoperative and postoperative creatinine values, CR-POSSUM physiological score, Charlson comorbidity index (CCI), perioperative and postoperative vasopressor use, postoperative acute kidney injury network (AKIN), postoperative intensive care requirements, duration of hospital stay and 30-day mortality will be recorded.
Detailed description
Blood will be taken and assessed from the participants preoperatively one day before surgery and creatinine, neutrophil, lymphocyte and neutrophil / lymphocyte values will be recorded.
Though the gastrointestinal surgery team is the same, randomization will not be applied for the primary operating surgeon and primary surgeon selection will not be performed. Participants in both groups will have age, gender, height, weight, body mass index (BMI), comorbidities, CCI, POSSUM physiologic score and ASA risk score recorded. After being taken to the operation room, standard monitoring (ECG, SO2, NIBP) will be performed. A peripheral venous route will be opened with an 18-gauge needle. Participants will be began 5 mL/kg/hr crystalloid (isolyte) infusion as standard. Later participants who accept will have an epidural catheter inserted at the thoracic 10-11 level. After ensuring hemodynamic stabilization in both groups, sedation will be provided with 0.03 mg/kg midazolam and arterial monitoring will be provided with radial artery cannulation with a 20-gauge peripheral cannula.
Induction and General Anesthesia Management:
For induction 1-2 mcg/kg fentanyl, 2 mg/kg propofol and 0.6 mg/kg rocuronium will be used, and participants will be orotracheally intubated after two minute ventilation. A MAQUET flow-I anesthesia device will be placed in volume control (VC) mode by setting to 8 mL/kg tidal volume and 12/min respiratory count according to ideal body weight with PetCO2 35-45 mmHg. Later, central venous catheterization will be performed on the right internal jugular vein using USG guidance. Sevoflurane (MAC 0.7-0.9) and remifentanil infusion (0.05-0.3 mcg/kg/min) will be used in anesthesia maintenance.
Monitoring:
After radial artery and central jugular vein catheterization in Group G, they will be linked to an EV1000 Flo-trac monitor and monitoring provided continuous mean arterial pressure (MAP) monitoring with heart rate (HR), stroke volume variation (SVV), central venous pressure (CVP), systemic vascular resistance index (SVRI) and cardiac index (CI) measured every minute. After monitoring blood gas will be taken and the initial value accepted as time-1 (t1). At 5 minute intervals, mean arterial pressure (MAP), momentary heart rate (HR) will be recorded, with CVP, CI, SVV, and SVRI recorded at 30 minute intervals for a total of 240 minutes (t1, t2, t3, t4, t5, t6, t7, t8, t9), urine amount and blood gas values (pH, PCO2, PO2, bicarbonate (HCO3), base minus (BM), lactate (lac), hemoglobin (Hb), hematocrit (Ht)) will also be recorded.
In Group L, radial arterial cannulation and central jugular venous catheterization will be performed with the first value during monitoring accepted as t1. Then HR and MPA will be recorded at 5-minute intervals, CVP at 30 minute intervals for a total of 240 minutes (t1, t2, t3, t4, t5, t6, t7, t8, t9) and urine amount and blood gas values (pH, PCO2, PO2, HCO3, BM, lac, Hb, Ht) will also be recorded.
Peroperative fluid management:
- Group G: Fluid management will be performed according to SVV and CI monitoring. When participants have SVV>10%, 250 cc crystalloid will be administered and when SVV fell below 10% during 30-minute monitoring standard (5 mL/kg/hr) crystalloid infusion continues. If SVV continues above 10%, a second fluid bolus of 250 cc colloid (minifluid challenge) will be administered. If the desired SVV level can not be reached, the Hct values will be examined. Blood replacement will be performed when Hct<30% in participants with coronary artery disease (CAD) and when Hct<25% for other groups. If the desired SVV level can not be reached in spite of blood replacement products, if CI will be below 2.5 L/min/m2 vasopressor will begun. If SVV will be at normal values with CI below 2.5 L/min/m2, inotrop will begun.
- Group L:
Fluid management will be performed according to MAP, HR and urine output. If peroperative urine amounts will be <0.5 mL/kg/hr during two-hour monitoring, with MAP<65 mmHg, HR>100/min for at least 30 minutes and CVP falls 20% compared to basal values, the same anesthesiologist will begin additional fluid replacement of 5 mL/kg/hr based on clinical experience. Blood product replacement will be provided at Hct<30% for those with coronary artery disease and at Hct<25% for other participants.
The operation durations, administered fluid types, fluid amounts and blood product amounts will be recorded. Participants having intensive care need preoperatively planned intensive care will have planned admission, while participants developing hemodynamic instability linked to peroperative surgery or anesthesia will be admitted as unplanned care. All participants will have creatinine, neutrophil, lymphocyte and neutrophil/lymphocyte values recorded in the 1st and 24th hours postoperative and participants with fever (>38 °C) in the 1st day will be recorded. Acute kidney injury network (AKIN) classification will be made according to creatinine values measured preoperatively and on the postoperative 1st day. In the postoperative 30-day period, duration of hospital stay, surgical and pulmonary complications, inotrop or vasopressor requirements, reason for admission to intensive care, and duration of stay in intensive care if required will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-directed fluid treatment | Active comparator | Other: Goal-directed fluid treatmentFluid management will be performed according to SVV and CI monitoring. When patients have SVV>10%, 250 cc crystalloid will be administered and when SVV fell below 10% during 30-minute monitoring standard (5 mL/kg/hr) crystalloid infusion continues. If SVV continues above 10%, a second fluid bolus of 250 cc colloid (minifluid challenge) will be administered. If the desired SVV level can not be reached, the Hct values will be examined. Blood replacement will be performed when Hct<30% in patients with coronary artery disease (CAD) and when Hct<25% for other patient groups. If the desired SVV level can not be reached in spite of blood replacement products, if CI will be below 2.5 L/min/m2 vasopressor will begun. If SVV will be at normal values with CI below 2.5 L/min/m2, inotrop will begun. |
| liberal fluid treatment | Active comparator | Other: Liberal Fluid TherapyFluid management will be performed according to MAP, HR and urine output. If peroperative urine amounts will be <0.5 mL/kg/hr during two-hour monitoring, with MAP<65 mmHg, HR>100/min for at least 30 minutes and CVP falls 20% compared to basal values, the same anesthesiologist will begin additional fluid replacement of 5 mL/kg/hr based on clinical experience. Blood product replacement will be provided at Hct<30% for those with coronary artery disease and at Hct<25% for other patients. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with major abdominal surgery
- ASA risk classification II-III
Key exclusion criteria (5 listed)
- Peripheral artery disease
- Not in sinus rhythm
- Peroperative major hemorrhage (more than 500 mL hemorrhage within 1 hour)
- Pregnant or breastfeeding
- Advanced degree of liver and renal failure
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 |
|---|---|---|
| Goal-directed fluid treatmentGoal-directed fluid treatment for major abdominal surgery | Other | Goal-directed fluid treatment |
| Liberal Fluid TherapyLiberal Fluid Therapy for major abdominal surgery | Other | liberal fluid treatment |
Primary outcome
Peroperative Hemodiynamic, Mean Arterial Pressure
Time frame: During the surgery
Mean arterial pressure (mmHg)
Peroperative Hemodiynamic, Kidney Function
Time frame: During the surgery
Urine output (ml/h)
Peroperative Hemodiynamic, Pulse
Time frame: During the surgery
Heart rate (beats per minute)
Peroperative Hemodiynamic, Fluid response
Time frame: During the surgery
Stroke Volume Variation (%)
Peroperative Hemodiynamic, Cardiac output
Time frame: During the surgery
Cardiac Index (l/min/m2)
1 secondary outcome
Number of Participants
Time frame: 5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-directed fluid treatment and Liberal Fluid Therapy in people with Goal-Directed Fluid Therapy and Hemodynamic Monitoring, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 13 Jul 2020. 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 Turkey (Türkiye). 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 withdrawn before enrolling participants, so there are no results.
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?
Peroperative Hemodiynamic, Mean Arterial Pressure (time frame: During the surgery). The study lists 5 primary outcomes in all. 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 Jul 2020.