Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05487222
Other study ID # R.19.12.704
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2020
Est. completion date September 20, 2021

Study information

Verified date August 2022
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date September 20, 2021
Est. primary completion date June 15, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
ICON
hemodynamics variability in response to different fluid regiemens

Locations

Country Name City State
Egypt Mansoura Oncology Center Mansoura Eldakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum creatinine level mg/dl 24 hours postoperative
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06351475 - Efficacy of Intraoperative Use of 20% Albumin Combined With Ringer Lactate Versus Ringer Lactate During Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy N/A
Not yet recruiting NCT04982016 - Effects of Fluid Therapy on Microcirculatory Reactivity N/A
Completed NCT03215797 - Phenylephrine or Norepinephrine for a Better Hemodynamic Stability Phase 3
Completed NCT04536324 - The Absorption Rate of Subcutaneous Infused Fluid
Completed NCT02977390 - Passive Leg Raise Induced Stroke Volume Changes in Elderly Prior to Elective Surgery Measured by LiDCOplusTM N/A
Recruiting NCT01415284 - ED50 Determination of Hydroxyethylstarch for Treatment of Hypotension During Cesarean Section Under Spinal Anesthesia Phase 4
Completed NCT03245372 - Goal Directed Therapy Versus Standard Care in Lung Resection Surgery (GDT-thorax Study). N/A
Recruiting NCT05606536 - The Impact of Intra-operative Fluid Infusion Rate on Microcirculation N/A
Terminated NCT03553394 - Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients N/A
Recruiting NCT05153837 - Effect of Oral Water in Healthy Volunteers on Cardiac Output, Regional Flow and Microcirculation in Healthy Volunteers N/A
Completed NCT03323580 - Effects of Intraoperative GDFT on the Postoperative Brain Edema N/A
Completed NCT03394833 - Hemodynamic Stability During Induction of Anaesthesia N/A
Completed NCT03280953 - Assessing Fluid Responsiveness With PWTT
Not yet recruiting NCT06256120 - Effect of Fluid Regimen on Acute Kidney Injury N/A
Recruiting NCT03178578 - A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy
Enrolling by invitation NCT04388995 - SVV and PPV Predict Fluid Responsiveness in Mechanically Ventilated Elderly Patients Under General Anesthesia N/A
Not yet recruiting NCT06396884 - Hemodynamic Optimization During Spinal Anesthesia in the Elderly
Recruiting NCT05369559 - Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department Early Phase 1
Recruiting NCT05054452 - Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children Using Transthoracic Echocardiography N/A
Completed NCT03060408 - Comparison of Fluid Requirements in Pancreatectomy: Laparotomy vs. Laparoscopy N/A