Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement — TIMI  

Outcomes Clinical Trial

Official title: A Randomized Pilot Study for Thermal Management in Patients With Interventional Minimally Invasive Valve Replacement

Status Completed

Clinical Trial Summary

It is known that perioperative hypothermia can influence the postoperative outcome negatively.

The most important complications are cardiac, increased blood loss with need for transfusion and a significantly increased wound infection rate.

The thermal redistribution after the induction of anesthesia is on of the reasons for perioperative hypothermia. Another reason is negative heat balance during surgery.

Further negative side effects of hypothermia are an increase of blood viscosity and thus a higher risk for thrombosis, coagulopathy and thus an increased risk of bleeding.

The aim of the study is to evaluate if patients with a perioperative active thermal management during an interventional minimal invasive valve replacement have a significantly higher body temperature at the end of the operation than patients without an active thermal management. Secondary outcome variables are complication rates, length of mechanical ventilation and length of ICU treatment.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Body Temperature
• Outcomes

• NCT number: NCT01176110
• Study type: Interventional
• Source: Charite University, Berlin, Germany
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Completion date: May 2011