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NCT05502835 Clinical Trial

Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis

Postoperative Complications Clinical Trial

Official title:
Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05502835
Other study ID # IRB00006379 GUT OEDEMA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 20, 2022
Est. completion date January 25, 2023

Study information
Verified date January 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

pulse pressure variation based intraoperative fluid therapy versus traditional fluid therapy for colonic cancer patients undergoing mass resection and anastomosis for maintaining adequate hydration without complications.

Description:

All Patients will be assigned randomly by using computerized program to one of the two equal groups. Patients will be (forty five patients per group): Group A ;( control group) Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 6 ml/kg/hr. Ringer's solution. Group B; Forty five patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation. Intraoperative fluid volume, hemodynamics, serum lactate and intestinal edema will be measured after induction of anesthesia and every hour till the end of the operation, length of the hospital stay, first time to gastrointestinal motion and postoperative complications are recorded.

Recruitment information / eligibility
Status Completed
Enrollment 90
Est. completion date January 25, 2023
Est. primary completion date January 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - American Society of Anesthesiologists physical status (ASA-PS) I and II Patients. - Patients scheduled for elective open colonic mass resection and anastomosis. Exclusion Criteria: - Serious cardiac arrhythmia. - Peripheral artery disease. - An ejection fraction below 30%. - A pulmonary pathology.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• pulse pressure variation
Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.
Other:
• conventional fluid management
Infusion of 6 ml/kg/hr. Ringer's solution.

Locations
Country Name City State
Egypt Ain shams university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative fluid volume calculated immediately after surgery
Secondary intraoperative blood pressure every ten minutes till the end of the surgery
Secondary lactate level every hour till the end of the surgery
Secondary POSTOPERATIVE COMPLICATIONS till one week after surgery
Secondary intestinal oedema intraoperatively after tumor resection
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