Goal Directed and Liberal Fluid Therapy

Goal Directed Fluid Therapy Compared to Liberal Fluid Therapy in Patients Subjected to Colorectal Surgery

The aim is to compare intraoperative goal directed fluid therapy (GDFT) versus liberal fluid therapy in patients undergoing elective colorectal surgery by using noninvasive electrical cardiometry. This study hypothesized that GDFT is better than liberal fluid therapy to provide sufficient intra-vascular fluid volume for adequate perfusion without impairing glycolcalyx function with fluid overload

Study Overview

• Status: Completed
• Conditions: Fluid Therapy
• Intervention / Treatment: Device: ICON

Detailed Description

Intraoperative fluid management for major abdominal and intestinal surgeries is quite important in terms of postoperative organ perfusion and complications. Many complications such as acute renal failure, hypotension, arrhythmia, and anastomosis leak may occur secondary to intraoperative hypovolemia whereas hypervolemia may cause pulmonary edema, postoperative pneumonia, prolonged mechanical ventilation, delayed wound healing, edema in the gastrointestinal system (GIS), and decreased GIS motility.

In the perioperative period, fluid therapy and gastrointestinal function may complement each other or complicate it. If fluid therapy is not optimal, it may cause delayed gastrointestinal function and avoid early oral intake. If gastrointestinal dysfunction develops in the perioperative period, it may lead to fluid and electrolyte loss and metabolic problems. Thus, the intraoperative fluid management of the patient is very important.

Accurate assessment of a patient's volume status is an important goal for the anesthetist in the operating theatre to achieve hemodynamic stability and adequate tissue oxygenation. Different intraoperative fluid management protocols are in use for this purpose. The most common one is conventional fluid management (CFM). Fluid replacement is managed according to clinical assessment and heart rate (HR), arterial blood pressure (ABP) and central venous pressure (CVP) monitorization.

While goal-directed fluid therapy (GDFT) is a perioperative strategy, where fluid administration targets continuously-measured hemodynamic variables, such as cardiac output, stroke volume, stroke volume variation, pulse pressure variation and other factors to guide intravenous and inotropic therapy, with the aim of maximizing tissue perfusion and oxygen delivery.

Cardiac output is assessed by static indices or dynamic indices. Static indices of cardiac preload such as central venous pressure (CVP) and pulmonary artery wedge pressure are of little help for decisions regarding volume replacement. Dynamic variables such as pulse pressure variation (PPV) and stroke volume variation (SVV) are increasingly used to detect the cyclic fluctuation of the arterial pressure wave in the mechanically ventilated patient in order to predict fluid responsiveness.

Direct measurement of SV using noninvasive techniques has become an accepted tool for stroke volume optimization and guiding fluid administration in highly risk surgical patients. Many technologies are used to measure stroke volume, including Doppler monitoring, bio impedance/reactance measurements, and arterial waveform analysis. So, when stroke volume optimization is used as the end point, it could improve the outcomes for surgical patients with good prediction of fluid administration.

Impedance cardiography (ICG) is an accurate technique for noninvasive determination of hemodynamic variables such as stroke volume (SV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), and systolic time ratio (STR). ICG use electrical impedance changes to generate waveform that depend on volume and velocity of blood injected into aorta as well as the force and rate of left ventricle contraction. From that curve beside heart rate and blood pressure, stroke volume ,COP ,SVR and other hemodynamic parameter are derived

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Eldakahlia
    • Mansoura, Eldakahlia, Egypt
      • Mansoura oncology center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This prospective, randomized, controlled study was conducted after a written informed consent will be obtained from all participants

Description

Inclusion Criteria:

• • patients scheduled for elective colorectal surgery

  • with (ASA) physical status I - II - of both gender aged 18-60 years old
  • Hb >12 g/dl & Hct >38%.

Exclusion Criteria:

• • Patient refusal

  • Patients with major cardiovascular problems with ejection fraction < 40 %
  • Renal impairment with serum creatinine >1.8 mg/dl .
  • Patients with hepatic dysfunction and coagulopathy.
  • Metabolic disorder, serum lactate > 4 mmol/L.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
• Liberal fluid group (L group) using traditional technique of fluid administration	Device: ICON; hemodynamics variability in response to different fluid regiemens
• Goal directed fluid group(G group) using stroke volume optimization	Device: ICON; hemodynamics variability in response to different fluid regiemens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum creatinine level	mg/dl	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stroke volume (SV)		Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
stroke volume variation (SVV)	percentage	Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
stroke volume index (SVI)	ml/m2	Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
cardiac index	L/minute/m2	Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours
cardiac output (COP)	L/minute	Basal preoperative, before induction of anesthesia (T1), just before skin incision (T2), then every 30 min until end of surgery then every 6 hour for 24 hours

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): September 20, 2021

Study Registration Dates

• First Submitted: December 28, 2021
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: fluid therapy, goal directed , liberal , colorectal surgery
• Other Study ID Numbers: R.19.12.704

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes