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Comparison of Body warming devices and clinical outcomes after Heart Surgery: randomized Clinical Trial

Comparison of Cutaneous Warming Devices and clinical outcomes in the postoperative period in Cardiac Surgery: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5t582g
Enrollment
Unknown
Registered
2018-07-11
Start date
2018-01-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia

Interventions

Intervention Group (IG): 95 hypothermic patients verified by Tympanic temperature below 36 ° C and greater than 32 ° C warmed with heating thermal blanket with forced air warming circulation at adm
Device

Sponsors

Universidade Federal de São Paulo
Lead Sponsor
Instituto Dante Pazzanese de Cardiologia
Collaborator

Eligibility

Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Age 18 years or older; submitted to elective coronary artery bypass grafting with Cardiopulmonary bypass; Intensive Care unit admission temperature below 36 ° C and greater than 32 ° C.

Exclusion criteria

Exclusion criteria: Other surgical corrections associated with coronary artery bypass grafting with Cardiopulmonary bypass; use of circulatory support devices, intra-aortic Balloon Counterpulsation; extracorporeal membrane oxygenation ; ventricular percutaneous circulatory assistance previus cardiac surgery; patients with chronic renal disease; intraoperative cardiac arrest, immunosuppressed patients; acquired or hereditary coagulation disorders; liver disease

Design outcomes

Primary

MeasureTime frame
Excessive bleeding in the immediate postoperative period, measured by the sum of the debit of all thoracic drains from the moment of arrival to intensive care unit, every hour for 24 hours. The outcome will be considered present if the sum of the chest drainage flow rates is greater than or equal to 150mL / h at any time or part of the hour.

Secondary

MeasureTime frame
Expected outcomes 1: Perioperative myocardial infarction Type 5 in the immediate postoperative period; myocardial infarction associated with miocardial reavascularization surgery verified when the measurement of the ischemic marker troponin in the blood ten times over the reference value, associated with another 1 of the following criteria: new pathological Q waves or new left bundle branch block verified on the electrocardiogram; echocardiogram with new segmentar changes;Angiographic confirmation of new native-bed graft occlusions. ;Expected outcomes 2: Heart Arrhythmias in the immediate postoperative period;medical diagnosis of atrial fibrillation; atrial flutter, supraventricular tachyarrhythmias; tachycardia;ventricular fibrillation; Bradiarrhythmias verified during cardiac monitoring and confirmed by 12 lead electrocardiogram within 24 hours of admission. ;Expected outcomes 3: Blood Transfusion;transfusion of blood or blood components such as: packed red blood cells; fresh frozen plasma; platelet concentrate; cryoprecipitate and factor VIIa within 24 hours of admission.;Expected outcomes 4: Immediate postoperative tympanic temperature behavior, verified by tympanic temperature measurements with intervals of measurements every 15 minutes in the first hour and after this period every 1 hour for 24 hours after paciente admission in intensive care unit

Countries

Brazil

Contacts

Public ContactAmanda Bezerra

Instituto Dante Pazzanese de Cardiologia

amandabezerra19@hotmail.com+55-011-50856479

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 16, 2026