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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).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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
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

Other trials in Turkey (Türkiye)

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:

  1. 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.
  2. 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 groups in NCT04265014
Study groupRoleWhat they receive
Goal-directed fluid treatmentActive comparatorFluid 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 treatmentActive comparatorFluid 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.

  1. Peroperative Hemodiynamic, Mean Arterial Pressure

    Mean arterial pressure (mmHg)

    Measured: During the surgery

  2. Peroperative Hemodiynamic, Kidney Function

    Urine output (ml/h)

    Measured: During the surgery

  3. Peroperative Hemodiynamic, Pulse

    Heart rate (beats per minute)

    Measured: During the surgery

  4. Peroperative Hemodiynamic, Fluid response

    Stroke Volume Variation (%)

    Measured: During the surgery

  5. Peroperative Hemodiynamic, Cardiac output

    Cardiac Index (l/min/m2)

    Measured: During the surgery

Secondary outcomes (1)
  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.

  1. First posted11 Feb 2020
  2. Study start1 Jan 2020
  3. Primary completion1 May 2020
  4. Study completion1 Jul 2020

Why it stopped: we didn't have any patient

Resources

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)
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

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.

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