Incidence and Risk Factors of Postoperative Hypothermia in Cardiac Surgery

NCT02244034 | Completed

• 1 other identifier: SI002
• Study Type: observational
• Target: 760
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Hypothermia in Patients With Cardiopulmonary Bypass

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours

Secondary Outcomes (1)

• predictors of postoperative hypothermia in patients with cardiopulmonary bypass.

  24 hours

Study Arms (1)

760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB

Procedure: hypothermia

Interventions

hypothermia PROCEDURE

760 patients who underwent open cardiac and/or thoracic aortic surgery using CPB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who had been underwent cardiac surgery with CPB during 2012-2013

You may qualify if:

• patients ≥ 18 years old

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of medicine Siriraj hospital

Bangkok, 10700, Thailand

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: instructor

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 18, 2014
• Study Start: January 1, 2013
• Primary Completion: December 31, 2013
• Study Completion: December 31, 2013
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

TH (1)