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Incidence and Risk Factors of Postoperative Hypothermia in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02244034
Recruitment Status : Completed
First Posted : September 18, 2014
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Chaowanan Khamtuikrua, Mahidol University

Brief 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. 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.


Condition or disease
Postoperative Hypothermia in Patients With Cardiopulmonary Bypass

Study Type : Observational
Actual Enrollment : 780 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Incidence and Risk Factors of Postoperative Hypothermia in Patients With Cardiopulmonary Bypass.
Actual Study Start Date : May 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Group/Cohort
1250 patients who had cardiac surgery wit



Primary Outcome Measures :
  1. incidence of postoperative hypothermia in patients with cardiopulmonary bypass. [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. predictors of postoperative hypothermia in patients with cardiopulmonary bypass. [ Time Frame: 12 hours ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who had been underwent cardiac surgery with CPB during 2012-2013
Criteria

Inclusion Criteria:

  • patients ≥ 18 years old

Exclusion Criteria:

  • patients with preoperative hyperthermia (> 37.8 °C) and hypothermia (< 36 °C).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244034


Locations
Thailand
Faculty of medicine Siriraj hospital
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University

Responsible Party: Chaowanan Khamtuikrua, instructor, Mahidol University
ClinicalTrials.gov Identifier: NCT02244034     History of Changes
Other Study ID Numbers: SI002
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms