HypothermiaNCT07192224
Efficacy of IV Fluid Warmer for the Prevention of Hypothermia
A study testing Hypothermia and Hotline in people with Hypothermia and Shivering, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hypothermia, Shivering
- What is being tested?
- Hypothermia and Hotline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2025to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years,
- ASA I-II,
- both Male \& female,
- elective gastrointestinal cancer surgery -
Who cannot join
- Preoperative core temperature greater than 37.2,
- severe endocrine respiratory \& cardiovascular disease. -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaukat Khanam Memorial Cancer Hospital LAHORE
Lahore, Punjab Province, 54000
About this study
Official title: Effect of Intravenous Fluid Warmer on Prevention of Hypothermia in Laparoscopic Gastrointestinal Cancer Surgeries During General Anesthesia
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.
Read the detailed description
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.
- Conditions
- Hypothermia, Shivering
- Being tested
- Hypothermia, Hotline
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypothermiaDevice
This study involves the comparison of 2 groups, one receiving warm fluids while the other group receiving room temperature fluids during surgeries.
HotlineDevice
Used as a fluid warmer.
| Study group | Role | What they receive |
|---|---|---|
| Hotline | Experimental | These patients had fluid via hotline. Receives: Device: Hotline |
| Placebo | Placebo comparator | Received fluid at room temperature. Receives: Device: Hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
hypothermia
Prevention of hypothermia
Measured: 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Mar 2025
- Primary completion15 Aug 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192224
- Sponsor's protocol ID
- IRB-23-03
- Status last verified
- Mar 2025
- First submitted
- 13 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: To maintain the confedentiality
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Fluid Warmer on Prevention of Hypothermia in Laparoscopic Gastrointestinal Cancer Surgeries During General Anesthesia
- ClinicalTrials.gov ID
- NCT07192224
- Acronym / sponsor ID
- IRB-23-03
- Conditions
- Hypothermia, Shivering
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shaukat Khanum Memorial Cancer Hospital & Research CentreUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Aug 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hotline | Experimental | Device: HotlineThese patients had fluid via hotline. |
| Placebo | Placebo comparator | Device: HypothermiaReceived fluid at room temperature. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years,
- ASA I-II,
- both Male \& female,
- elective gastrointestinal cancer surgery -
Key exclusion criteria (2 listed)
- Preoperative core temperature greater than 37.2,
- severe endocrine respiratory \& cardiovascular disease. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypothermiaThis study involves the comparison of 2 groups, one receiving warm fluids while the other group receiving room temperature fluids during surgeries. | Device | Placebo |
| HotlineUsed as a fluid warmer. | Device | Hotline |
Primary outcome
hypothermia
Time frame: 5-6 months
Prevention of hypothermia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Undecided. To maintain the confedentiality
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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypothermia and Hotline in people with Hypothermia and Shivering, run by Shaukat Khanum Memorial Cancer Hospital & Research Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hypothermia (time frame: 5-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.