NCT05502835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

August 20, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

August 2, 2022

Last Update Submit

January 27, 2023

Conditions

Intraoperative Fluid VolumeHemodynamicsSerum LactateIntestinal EdemaLength of the Hospital StayFirst Time to Gastrointestinal MotionPostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Intraoperative fluid volume

    calculated immediately after surgery

Secondary Outcomes (4)

  • 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

Study Arms (2)

conventional fluid management group

EXPERIMENTAL

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

ppv group

ACTIVE COMPARATOR

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

Interventions

pulse pressure variationDEVICE

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

ppv group
conventional fluid managementOTHER

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

conventional fluid management group

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsparticipant eligibility is based on self-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists physical status (ASA-PS) I and II Patients.
  • Patients scheduled for elective open colonic mass resection and anastomosis.

You may not qualify if:

  • Serious cardiac arrhythmia.
  • Peripheral artery disease.
  • An ejection fraction below 30%.
  • A pulmonary pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, 20, Egypt

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesia

Study Record Dates

First Submitted

August 2, 2022

First Posted

August 16, 2022

Study Start

August 20, 2022

Primary Completion

January 20, 2023

Study Completion

January 25, 2023

Last Updated

January 30, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)