- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04533698
Impact of Fluid Resuscitation Protocol on the Incidence of Reoperation for Bleeding After Emergency Cardiopulmonary Bypass Grafting (Volu-CABG)
April 3, 2025 updated by: Alexa Hollinger, University Hospital, Basel, Switzerland
This is a retrospective data analysis of patients that underwent elective or emergency cardiopulmonary bypass.
Resternotomy due to bleeding is frequent after sternotomy.
Also due to implementation of Argipressin into clinical practice fluid resuscitation protocol has changed to more vasopressors and less fluid within the past five years.
The investigators want to explore the influence of volume resuscitation protocol on incidence of rethoracotomy during the past twenty years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
265
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
All patients that underwent elective or emergency aortocoronary bypass.
Description
Inclusion Criteria:
- All patients that underwent elective or emergency aortocoronary bypass at the University Hospital Basel between 2009 and 2020.
Exclusion Criteria:
- None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Resternotomy
|
No intervention is performed.
Reasons for resternotomy (coagulation, fluid balance and other) are retrospectively assessed.
|
|
No resternotomy
|
No intervention is performed.
Reasons for avoidance resternotomy (coagulation, fluid balance and other) are retrospectively assessed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Resternotomy
Time Frame: 7 days
|
Resternotomy yes or no after elective or emergency aortocoronary bypass
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2009
Primary Completion (Actual)
May 31, 2021
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
August 31, 2020
Study Record Updates
Last Update Posted (Actual)
April 4, 2025
Last Update Submitted That Met QC Criteria
April 3, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01833
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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