Postoperative Hypothermia in Patients With Cardiopulmonary BypassNCT02244034
Incidence and Risk Factors of Postoperative Hypothermia in Cardiac Surgery
An observational study of Postoperative Hypothermia in Patients With Cardiopulmonary Bypass, run by Mahidol University at 1 site in Thailand.
Trial summary
Background: Postoperative hypothermia may result in relevant complications such as adverse cardiovascular events, wound infection, and coagulopathy with consecutive blood loss. Patients with open cardiac surgery using cardiopulmonary bypass are particular at risk for hypothermia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Hypothermia in Patients With Cardiopulmonary Bypass
- What is being tested?
- hypothermia
- Type of treatment
- Surgery or procedure
- How many people
- 760 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2013to 31 Dec 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who had been underwent cardiac surgery with CPB during 2012-2013
Who may be able to join
- patients ≥ 18 years old
Who cannot join
- patients with preoperative hyperthermia (> 37.8 °C) and hypothermia (< 36 °C).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Risk Factors of Postoperative Hypothermia in Patients With Cardiopulmonary Bypass.
Background: Postoperative hypothermia may result in relevant complications such as adverse cardiovascular events, wound infection, and coagulopathy with consecutive blood loss. Patients with open cardiac surgery using cardiopulmonary bypass are particular at risk for hypothermia. The study of Karalapillai and coworkers, analyzing a huge database incl. 43,158 patients with CPB, revealed 66% of them experiencing postoperative hypothermia during the first 24 hours and 0.3% longer than that. During cardiac surgery great parts of body surface including wound surface are exposed. Many of these patients receive large amounts of infusions and transfusions, and undergo hemodilution during CPB, which may additionally contribute to development of hypothermia.
Objective of the planned study is to find out incidence and duration of postoperative hypothermia and also risk factors for hypothermia in cardiac patients. Further objective is the incidence of postoperative complications and its relation to postoperative core temperature.
Read more
Methods: A retrospective chart review 780 patients who had been underwent cardiac surgery with CPB Included are patients ≥ 18 years old. Excluded are patients with preoperative hyperthermia (> 37.8 °C) and hypothermia (> 36 °C).
The following parameters will be recorded: temperature is measured at ICU after arrived and after 6 hours which is primary outcome, biometric data include age, sex, body weight, height, ASA physical status, surgical procedure includes emergency cases, anesthetic and surgical (bypass-) times, infusion/transfusion-regimen, blood loss and urine output, coolest temperature during bypass, method of temperature protection, and the outcome of operation .
All data will be described in number and percent and Pearson chi-square method will be used for analyze correlation between hypothermia and risk factor . P-value <0.05 will be defined to significant.
- Being tested
- hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypothermiaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB | Not described Receives: Procedure: hypothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative hypothermia in patients with cardiopulmonary bypass.
Upon arrival at the Cardiac Surgical Intensive Care Unit (CSICU), body temperature was measured using an infrared tympanic membrane thermometer. Postoperative hypothermia, which was defined as the body temperature < 36 degrees C upon arrival at the CSICU.
Measured: 24 hours
Secondary outcomes (1)
predictors of postoperative hypothermia in patients with cardiopulmonary bypass.
Predictors such as age, sex, body surface area, emergency surgery, time of operation, time of cardiopulmonary bypass time, fluid and blood component administer will be analyze.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study start1 Jan 2013
- Primary completion31 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Hypothermia in Patients With Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaowanan Khamtuikrua, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244034
- Sponsor's protocol ID
- SI002
- Status last verified
- Apr 2022
- First submitted
- 15 Sep 2014
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Postoperative Hypothermia in Patients With Cardiopulmonary Bypass.
- ClinicalTrials.gov ID
- NCT02244034
- Acronym / sponsor ID
- SI002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 18 Sep 2014 (estimated)
- 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.
Background: Postoperative hypothermia may result in relevant complications such as adverse cardiovascular events, wound infection, and coagulopathy with consecutive blood loss. Patients with open cardiac surgery using cardiopulmonary bypass are particular at risk for hypothermia. The study of Karalapillai and coworkers, analyzing a huge database incl. 43,158 patients with CPB, revealed 66% of them experiencing postoperative hypothermia during the first 24 hours and 0.3% longer than that. During cardiac surgery great parts of body surface including wound surface are exposed. Many of these patients receive large amounts of infusions and transfusions, and undergo hemodilution during CPB, which may additionally contribute to development of hypothermia.
Objective of the planned study is to find out incidence and duration of postoperative hypothermia and also risk factors for hypothermia in cardiac patients. Further objective is the incidence of postoperative complications and its relation to postoperative core temperature.
Methods: A retrospective chart review 780 patients who had been underwent cardiac surgery with CPB Included are patients ≥ 18 years old. Excluded are patients with preoperative hyperthermia (> 37.8 °C) and hypothermia (> 36 °C).
The following parameters will be recorded: temperature is measured at ICU after arrived and after 6 hours which is primary outcome, biometric data include age, sex, body weight, height, ASA physical status, surgical procedure includes emergency cases, anesthetic and surgical (bypass-) times, infusion/transfusion-regimen, blood loss and urine output, coolest temperature during bypass, method of temperature protection, and the outcome of operation .
All data will be described in number and percent and Pearson chi-square method will be used for analyze correlation between hypothermia and risk factor . P-value <0.05 will be defined to significant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB | – | Procedure: hypothermia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who had been underwent cardiac surgery with CPB during 2012-2013
Key inclusion criteria (1 listed)
- patients ≥ 18 years old
Key exclusion criteria (1 listed)
- patients with preoperative hyperthermia (> 37.8 °C) and hypothermia (< 36 °C).
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 |
|---|---|---|
| hypothermia | Procedure or surgery | 760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB |
Primary outcome
incidence of postoperative hypothermia in patients with cardiopulmonary bypass.
Time frame: 24 hours
Upon arrival at the Cardiac Surgical Intensive Care Unit (CSICU), body temperature was measured using an infrared tympanic membrane thermometer. Postoperative hypothermia, which was defined as the body temperature < 36 degrees C upon arrival at the CSICU.
1 secondary outcome
predictors of postoperative hypothermia in patients with cardiopulmonary bypass.
Time frame: 24 hours
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 14 Apr 2022.
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?
An observational study of Postoperative Hypothermia in Patients With Cardiopulmonary Bypass, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 1 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 14 Apr 2022. 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 Thailand. 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. 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?
incidence of postoperative hypothermia in patients with cardiopulmonary bypass. (time frame: 24 hours). 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 14 Apr 2022.