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

January 27, 2023 updated by: RAMY AHMED, Ain Shams University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

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
      • Cairo, Egypt, 20
        • Ain Shams University

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: conventional fluid management group
patients will do elective open colonic mass resection and anastomosis will receive Infusion of 6 ml/kg/hr. Ringer's solution.
Other: conventional fluid management
Infusion of 6 ml/kg/hr. Ringer's solution.
Active Comparator: ppv group
patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.
Device: pulse pressure variation
Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative fluid volume
Time Frame: calculated immediately after surgery
calculated immediately after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
intraoperative blood pressure
Time Frame: every ten minutes till the end of the surgery
every ten minutes till the end of the surgery
lactate level
Time Frame: every hour till the end of the surgery
every hour till the end of the surgery
POSTOPERATIVE COMPLICATIONS
Time Frame: till one week after surgery
till one week after surgery
intestinal oedema
Time Frame: intraoperatively after tumor resection
intraoperatively after tumor resection

Collaborators and Investigators

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

Sponsor

Ain Shams 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)

August 20, 2022

Primary Completion (Actual)

January 20, 2023

Study Completion (Actual)

January 25, 2023

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

August 15, 2022

First Posted (Actual)

August 16, 2022

Study Record Updates

Last Update Posted (Estimate)

January 30, 2023

Last Update Submitted That Met QC Criteria

January 27, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006379 GUT OEDEMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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