Personalized Blood Pressure Management (IMPROVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03442907|
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : September 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Blood Pressure Intraoperative Hypotension Postoperative Complications||Procedure: 24 hour blood pressure measurement, fluids, vasopressors Procedure: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||368 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Intraoperative Blood Pressure Management Based on the Individual Blood Pressure Profile: Impact on Postoperative Organ Function|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
Experimental: Study group
The intraoperative blood pressure target for all patients in the study group is the mean arterial pressure (+ 10mmHg maximum) derived from the prior 24-hour blood pressure measurement.
To achieve the blood pressure target, fluid or vasoactive substances will be used.
Procedure: 24 hour blood pressure measurement, fluids, vasopressors
Targeting individual blood blood pressure values during surgical procedures
Active Comparator: Control group
Study patients of the control group are treated according to the standard operating procedures (SOP) of the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf.
Procedure: Standard of Care
Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf
- Composite endpoint: Incidence of POCD or delirium [ Time Frame: 3rd-7th postoperative day ]POCD is measured on the basis of a neuropsychological test battery and the delirium on the basis of the CAM-ICU test.
- Kidney function [ Time Frame: 24, 48 and 72 hrs after surgery ]Glomerular filtration rate; calculated 24h, 48h and 72h after surgery (Cockcroft-Gault equation)
- cardiac ischemia [ Time Frame: 6 hours after surgery ]high-sensitive troponin T measurements are performed prior and 6 hours after surgery
- length of hospital stay [ Time Frame: 30 days ]
- 30-day mortality [ Time Frame: 30 days ]
- 30-day morbidity [ Time Frame: 30 days ]European perioperative outcome definitions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442907
|Contact: Julia Nicklas, Dremail@example.com|
|Contact: Bernd Saugel, Drfirstname.lastname@example.org|
|Klinik und Poliklinik für Anästhesiologie, Zentrum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Hamburg-Eppendorf||Recruiting|
|Hamburg, Germany, 20246|
|Contact: Bernd Saugel, MD +4940741018866 email@example.com|
|Contact: Julia Nicklas, MD +4940741018867 firstname.lastname@example.org|