search
Back to results

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

Primary Purpose

Intraoperative Fluid Volume, Hemodynamics, Serum Lactate

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulse pressure variation
conventional fluid management
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intraoperative Fluid Volume

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ain shams university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

conventional fluid management group

ppv group

Arm Description

patients will do elective open colonic mass resection and anastomosis will receive Infusion of 6 ml/kg/hr. Ringer's solution.

patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.

Outcomes

Primary Outcome Measures

Intraoperative fluid volume

Secondary Outcome Measures

intraoperative blood pressure
lactate level
POSTOPERATIVE COMPLICATIONS
intestinal oedema

Full Information

First Posted
August 2, 2022
Last Updated
January 27, 2023
Sponsor
Ain Shams University
search

1. Study Identification

Unique Protocol Identification Number
NCT05502835
Brief Title
Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis
Official Title
Pulse Pressure Variation Based Intraoperative Fluid Management Versus Traditional Fluid Management for Colonic Cancer Patients Undergoing Mass Resection and Anastomosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraoperative Fluid Volume, Hemodynamics, Serum Lactate, Intestinal Edema, Length of the Hospital Stay, First Time to Gastrointestinal Motion, Postoperative Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional fluid management group
Arm Type
Experimental
Arm Description
patients will do elective open colonic mass resection and anastomosis will receive Infusion of 6 ml/kg/hr. Ringer's solution.
Arm Title
ppv group
Arm Type
Active Comparator
Arm Description
patients will do elective open colonic mass resection and anastomosis. Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.
Intervention Type
Device
Intervention Name(s)
pulse pressure variation
Intervention Description
Infusion of 2 ml/kg/hr. Ringer's solution guided by pulse pressure variation.
Intervention Type
Other
Intervention Name(s)
conventional fluid management
Intervention Description
Infusion of 6 ml/kg/hr. Ringer's solution.
Primary Outcome Measure Information:
Title
Intraoperative fluid volume
Time Frame
calculated immediately after surgery
Secondary Outcome Measure Information:
Title
intraoperative blood pressure
Time Frame
every ten minutes till the end of the surgery
Title
lactate level
Time Frame
every hour till the end of the surgery
Title
POSTOPERATIVE COMPLICATIONS
Time Frame
till one week after surgery
Title
intestinal oedema
Time Frame
intraoperatively after tumor resection

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
participant eligibility is based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ain shams university
City
Cairo
ZIP/Postal Code
20
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs