Efficacy of IV Fluid Warmer for the Prevention of Hypothe... | NCT07192224

Studies
Efficacy of IV Fluid Warmer for the Prevention of Hypothermia

NCT07192224

Sponsor

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Status

Completed

Last Update Posted

Sep 25, 2025Actual

Enrollment

84Actual

Phase

Not Applicable

Conditions

Hypothermia
Shivering

Interventions

Hypothermia
Hotline

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Aug 15, 2025Actual

Completion Date

Sep 2, 2025Actual

First Submitted Date

Sep 13, 2025

First Submission Date that Met QC Criteria

Sep 23, 2025

First Posted Date

Sep 25, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2025

Last Update Posted Date

Sep 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hotline	Experimental	These patients had fluid via hotline.	Device: Hotline
Placebo	Placebo Comparator	Received fluid at room temperature.	Device: Hypothermia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypothermia	Device	This study involves the comparison of 2 groups, one receiving warm fluids while the other group receiving room temperature fluids during surgeries.	Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hypothermia	Prevention of hypothermia	5-6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaukat Khanam Memorial Cancer Hospital LAHORE		Lahore	Punjab Province	54000	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

To maintain the confedentiality

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007035	Hypothermia

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided