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

NCT ID: NCT05502835

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-20

Study Completion Date

2023-01-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Intraoperative Fluid Volume Hemodynamics Serum Lactate Intestinal Edema Length of the Hospital Stay First Time to Gastrointestinal Motion Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

conventional fluid management

Intervention Type OTHER

Infusion of 6 ml/kg/hr. Ringer's solution.

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.

Group Type ACTIVE_COMPARATOR

pulse pressure variation

Intervention Type DEVICE

Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

Interventions

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pulse pressure variation

Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

Intervention Type DEVICE

conventional fluid management

Infusion of 6 ml/kg/hr. Ringer's solution.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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RAMY AHMED

Assistant Professor of Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain shams university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB00006379 GUT OEDEMA

Identifier Type: -

Identifier Source: org_study_id

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