Hypothermia Clinical Trial
Official title:
Heated Humidified Breathing Circuit Rewarming in Hypothermic Post Cardiopulmonary Bypass Patients.
NCT number | NCT03697122 |
Other study ID # | Pro00100711 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | June 15, 2019 |
Verified date | July 2020 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hypothermia on admission to the intensive care unit (ICU) following cardiopulmonary bypass (CPB) is common. The investigators propose that rewarming hypothermic (≤ 35 C) patients admitted to the intensive care unit following procedures using CPB with heated humidified breathing circuits (HHBC) in addition to conventional forced air warming blankets will shorten time to normothermia. Secondarily it may shorten time to extubation, improve coagulopathy, and metabolic derangements seen with hypothermia.
Status | Completed |
Enrollment | 14 |
Est. completion date | June 15, 2019 |
Est. primary completion date | June 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Admission to intensive care unit following surgical procedure involving cardiopulmonary bypass. - Admission temperature = 35.0 C. Exclusion Criteria: - Patients placed on extracorporeal membrane oxygenation intra-operatively, or during first 24 hours after ICU admission. - Any additional surgical procedures in the first 24 hours days after initial surgery e.g. Chest exploration for bleeding, Open Chest, Non-cardiac surgery such as colectomy for ischemic gut, etc. |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Hospital | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to Normothermia | Core temperature normothermia defined as >=36.5 C. | up to 24 hours post admission to intensive care unit | |
Secondary | Time to Extubation | Time from admission to time of extubation. Followup was truncated at 24 hours and if patient had not been extubated at that time they were assigned a value of 24 hours. | up to 24 hours post admission to intensive care unit | |
Secondary | Coagulopathy as Measured by Need for Transfusion of Blood Product | Assessed via number of transfusions of red blood cells, fresh frozen plasma, platelets, cryoprecipitate. | 24 hours post admission to intensive care unit | |
Secondary | Metabolic Derangement as Measured by Time to Normal pH | Assessed via blood gas analysis. Normal pH defined as 7.35-7.45. | up to 24 hours post admission to intensive care unit | |
Secondary | Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Prothrombin Time | Laboratory assessment of Prothrombin Time with normal defined as 9.5-13.1 seconds. | 24 hours post admission to intensive care unit | |
Secondary | Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of INR | Laboratory assessment of international normalised ratio (INR) with normal defined as 0.9-1.1. | 24 hours post admission to intensive care unit | |
Secondary | Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Act Partial Thromboplastin Time | Laboratory assessment of Act Partial Thromboplastin Time with normal defined as 26.8-37.1 seconds. | 24 hours post admission to intensive care unit | |
Secondary | Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Fibrinogen. | Laboratory assessment of fibrinogen levels with normal defined as 213-435 mg/dL. | 24 hours post admission to intensive care unit | |
Secondary | Number of Subjects With Abnormal Coagulopathy as Measured by Laboratory Assessment of Platelet Count | Laboratory assessment of platelet count with normal defined as 150 - 450 x10ˆ9/L. | 24 hours post admission to intensive care unit |
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