- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04767685
The Bern Perioperative Biobank (BPBB)
November 14, 2022 updated by: University Hospital Inselspital, Berne
The Bern Perioperative Biobank to Define Perioperative Changes of Molecular Markers of Perioperative Organo-dysfunctions, Inflammation, Adverse Events and Disease Progression
The goal of the research is to define clinically relevant molecular markers for increased risk of peri-/ postoperative organo-dysfunctions, inflammation, adverse events and disease progression.
To better understand the perioperative impact the investigators aim to determine perioperative levels of molecular markers over time in the available samples and clinical data of the Bern perioperative Biobank (BPBB) cohort to finally increase quality of perioperative care of patients by permitting preventive measures to be taken early in patients at risk.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
547
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bern, Switzerland, 3010
- Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for non-emergency surgery
Description
Inclusion Criteria:
- 18 years and older
- Written informed consent
- Non-emergency surgery
Exclusion Criteria
- Transient incapacity to consent or insufficient time (< 6h) to consider study participation
- No informed consent
- Cognitive impairment/Patients unable to consent
- Patients who retrospectively expressed their wish to be excluded
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 |
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All patients
Consenting patients undergoing non-emergency surgery with anesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing the change of the metabolic profile in the perioperative setting
Time Frame: Before induction of anesthesia as baseline
|
Surgery causes significant disruption of physiologic metabolism.
The investigators currently lack specific markers to assess change of the metabolic profile in the perioperative setting.
The investigators aim to identify metabolic markers and their change in the perioperative period in association with patients' clinical outcome.
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Before induction of anesthesia as baseline
|
Assessing the change of the metabolic profile in the perioperative setting
Time Frame: Ca. 2-5hours later upon finishing the surgery
|
Surgery causes significant disruption of physiologic metabolism.
The investigators currently lack specific markers to assess change of the metabolic profile in the perioperative setting.
The investigators aim to identify metabolic markers and their change in the perioperative period in association with patients' clinical outcome.
|
Ca. 2-5hours later upon finishing the surgery
|
Assessing the change of the metabolic profile in the perioperative setting
Time Frame: On postoperative day 1 during the morning round between 07:30-9:00am
|
Surgery causes significant disruption of physiologic metabolism.
The investigators currently lack specific markers to assess change of the metabolic profile in the perioperative setting.
The investigators aim to identify metabolic markers and their change in the perioperative period in association with patients' clinical outcome.
|
On postoperative day 1 during the morning round between 07:30-9:00am
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Frank Stüber, Prof. MD, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
- Study Director: Markus M Lüdi, MD, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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, 2011
Primary Completion (Actual)
December 1, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
December 16, 2020
First Submitted That Met QC Criteria
February 22, 2021
First Posted (Actual)
February 23, 2021
Study Record Updates
Last Update Posted (Actual)
November 15, 2022
Last Update Submitted That Met QC Criteria
November 14, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 041/09f
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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