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

Sponsor

Ain Shams University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05502835

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intraoperative Fluid Volume Hemodynamics Serum Lactate Intestinal Edema Length of the Hospital Stay First Time to Gastrointestinal Motion Postoperative Complications	Device: pulse pressure variation Other: conventional fluid management	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Intraoperative fluid volume [calculated immediately after surgery]

Secondary Outcome Measures

intraoperative blood pressure [every ten minutes till the end of the surgery]
lactate level [every hour till the end of the surgery]
POSTOPERATIVE COMPLICATIONS [till one week after surgery]
intestinal oedema [intraoperatively after tumor resection]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

RAMY AHMED, Assistant Professor of Anesthesia, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05502835

Other Study ID Numbers:

IRB00006379 GUT OEDEMA

First Posted:

Aug 16, 2022

Last Update Posted:

Aug 16, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colonic Neoplasms

Postoperative Complications

Study Results

No Results Posted as of Aug 16, 2022