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Clinical Trials/NCT02244034
NCT02244034
Completed
Not Applicable

Incidence and Risk Factors of Postoperative Hypothermia in Patients With Cardiopulmonary Bypass.

Mahidol University1 site in 1 country760 target enrollmentJanuary 1, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Hypothermia in Patients With Cardiopulmonary Bypass
Sponsor
Mahidol University
Enrollment
760
Locations
1
Primary Endpoint
incidence of postoperative hypothermia in patients with cardiopulmonary bypass.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2013
End Date
December 31, 2013
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Chaowanan Khamtuikrua

instructor

Mahidol University

Eligibility Criteria

Inclusion Criteria

  • patients ≥ 18 years old

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • predictors of postoperative hypothermia in patients with cardiopulmonary bypass.(24 hours)

Study Sites (1)

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