Goal Directed and Liberal Fluid Therapy

August 2, 2022 updated by: Mona Gad mostafa, Mansoura University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
• 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
serum creatinine level
Time Frame: 24 hours postoperative
mg/dl
24 hours postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
stroke volume (SV)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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