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Fluid TherapyNCT05487222

Goal Directed and Liberal Fluid Therapy

An observational study of Fluid Therapy, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Fluid Therapy
What is being tested?
ICON
Type of treatment
Medical device
How many people
100 participants
Where
1 siteEgypt
Study dates
10 Jan 2020to 20 Sep 2021
Phase
Observational
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 Any age
  • All sexes
  • Child, Adult, Older adult

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

Who may be able to join

  • • 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%.

Who cannot join

  • • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mansoura Oncology Center

    Al Mansurah, Eldakahlia

Other trials in Egypt

About this study

Official title: 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

Read the 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

Conditions
Fluid Therapy
Being tested
ICON
Keywords
fluid therapy, goal directed , liberal , colorectal surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICONDevice

    hemodynamics variability in response to different fluid regiemens

Study groups in NCT05487222
Study groupRoleWhat they receive
• Liberal fluid group (L group) using traditional technique of fluid administrationNot described
Receives: Device: ICON
• Goal directed fluid group(G group) using stroke volume optimizationNot described
Receives: Device: ICON

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. serum creatinine level

    mg/dl

    Measured: 24 hours postoperative

Secondary outcomes (5)
  1. stroke volume (SV)

    Measured: 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

  2. stroke volume variation (SVV)

    percentage

    Measured: 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

  3. stroke volume index (SVI)

    ml/m2

    Measured: 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

  4. cardiac index

    L/minute/m2

    Measured: 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

  5. cardiac output (COP)

    L/minute

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Aug 2022
  2. Study start10 Jan 2020
  3. Primary completion15 Jun 2021
  4. Study completion20 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05487222
Sponsor's protocol ID
R.19.12.704
Status last verified
Aug 2022
First submitted
28 Dec 2021
Last updated
4 Aug 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Fluid Therapy, run by Mansoura University at 1 site in Egypt.

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 3 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: finished, as of the sponsor's last update on 4 Aug 2022. 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

serum creatinine level (time frame: 24 hours postoperative). 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 4 Aug 2022.

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