NCT07192224

Brief Summary

This study focuses on the importance of the maintenance of body temperature during the surgeries. This study involves the comparison of 2 groups, one receiving warm fluids while the other group receiving room temperature fluids during surgeries.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2025

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 25, 2025

Completed
Last Updated

September 25, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

September 13, 2025

Last Update Submit

September 23, 2025

Conditions

HypothermiaShivering

Outcome Measures

Primary Outcomes (1)

  • hypothermia

    Prevention of hypothermia

    5-6 months

Study Arms (2)

Hotline

EXPERIMENTAL

These patients had fluid via hotline.

Device: Hotline

Placebo

PLACEBO COMPARATOR

Received fluid at room temperature.

Device: Hypothermia

Interventions

HypothermiaDEVICE

This study involves the comparison of 2 groups, one receiving warm fluids while the other group receiving room temperature fluids during surgeries.

Placebo
HotlineDEVICE

Used as a fluid warmer.

Hotline

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 years,
  • ASA I-II,
  • both Male \& female,
  • elective gastrointestinal cancer surgery -

You may not qualify if:

  • Preoperative core temperature greater than 37.2,
  • severe endocrine respiratory \& cardiovascular disease. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaukat Khanam Memorial Cancer Hospital LAHORE

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2025

First Posted

September 25, 2025

Study Start

March 1, 2025

Primary Completion

August 15, 2025

Study Completion

September 2, 2025

Last Updated

September 25, 2025

Record last verified: 2025-03

Locations

PA(1)