Goal Directed and Liberal Fluid Therapy

NCT05487222 | Completed DMC FDA Device

• 1 other identifier: R.19.12.704
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Fluid Therapy

Keywords

fluid therapy, goal directed , liberal , colorectal surgery

Outcome Measures

Primary Outcomes (1)

• serum creatinine level

  mg/dl

  24 hours postoperative

Secondary Outcomes (5)

• 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)

  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)

  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

  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)

  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

Study Arms (2)

• Liberal fluid group (L group) using traditional technique of fluid administration

Device: ICON

• Goal directed fluid group(G group) using stroke volume optimization

Device: ICON

Interventions

ICON DEVICE

hemodynamics variability in response to different fluid regiemens

• Goal directed fluid group(G group) using stroke volume optimization; • Liberal fluid group (L group) using traditional technique of fluid administration

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Oncology Center

Al Mansurah, Eldakahlia, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 28, 2021
• First Posted: August 4, 2022
• Study Start: January 10, 2020
• Primary Completion: June 15, 2021
• Study Completion: September 20, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

EG (1)