Comparison of Goal-directed and Liberal Fluid Management

NCT04265014 | Withdrawn DMC

• 1 other identifier: 165/2017
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Goal-Directed Fluid Therapy; Hemodynamic Monitoring; Fluid Management

Outcome Measures

Primary Outcomes (5)

• Peroperative Hemodiynamic, Mean Arterial Pressure

  Mean arterial pressure (mmHg)

  During the surgery

• Peroperative Hemodiynamic, Kidney Function

  Urine output (ml/h)

  During the surgery

• Peroperative Hemodiynamic, Pulse

  Heart rate (beats per minute)

  During the surgery

• Peroperative Hemodiynamic, Fluid response

  Stroke Volume Variation (%)

  During the surgery

• Peroperative Hemodiynamic, Cardiac output

  Cardiac Index (l/min/m2)

  During the surgery

Secondary Outcomes (1)

• Number of Participants

  5 months

Study Arms (2)

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.

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.

Other: Liberal Fluid Therapy

Interventions

Goal-directed fluid treatment OTHER

Goal-directed fluid treatment for major abdominal surgery

Goal-directed fluid treatment

Liberal Fluid Therapy OTHER

Liberal Fluid Therapy for major abdominal surgery

liberal fluid treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with major abdominal surgery
• ASA risk classification II-III

You may not qualify if:

• 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

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakırkoy Sadi Konuk Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 11, 2020
• Study Start: January 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

TU (1)