AnesthesiaBPBBNCT04767685
The Bern Perioperative Biobank
An observational study of Anesthesia and Surgical Procedure, Operative, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Surgical Procedure, Operative
- How many people
- 547 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for non-emergency surgery
Who may be able to join
- 18 years and older
- Written informed consent
- Non-emergency surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Bern, 3010
About this study
Official title: 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.
- Conditions
- Anesthesia, Surgical Procedure, Operative
- Keywords
- Genetic association study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients | Consenting patients undergoing non-emergency surgery with anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change of the metabolic profile in the perioperative setting
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.
Measured: Before induction of anesthesia as baseline
Assessing the change of the metabolic profile in the perioperative setting
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.
Measured: Ca. 2-5hours later upon finishing the surgery
Assessing the change of the metabolic profile in the perioperative setting
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.
Measured: On postoperative day 1 during the morning round between 07:30-9:00am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study startJan 2011
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 547 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Stüber, Prof. MD, Study chair, Department of Anaesthesiology and Pain Medicine, Inselspital, University of BernMarkus M Lüdi, MD, Study director, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767685
- Sponsor's protocol ID
- 041/09f
- Acronym
- BPBB
- Status last verified
- Nov 2022
- First submitted
- 16 Dec 2020
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bello C, Filipovic MG, Huber M, Flannery S, Kobel B, Fischer R, Kessler BM, Raber L, Stueber F, Luedi MM. Discovery of plasma proteome markers associated with clinical outcome and immunological stress after cardiac surgery. Front Cardiovasc Med. 2023 Dec 22;10:1287724. doi: 10.3389/fcvm.2023.1287724. eCollection 2023.
PubMed 38379859Heinisch PP, Mihalj M, Huber M, Schefold JC, Hartmann A, Walter M, Steinhagen-Thiessen E, Schmidli J, Stuber F, Raber L, Luedi MM. Impact of Lipoprotein(a) Levels on Perioperative Outcomes in Cardiac Surgery. Cells. 2021 Oct 21;10(11):2829. doi: 10.3390/cells10112829.
PubMed 34831051
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bern Perioperative Biobank to Define Perioperative Changes of Molecular Markers of Perioperative Organo-dysfunctions, Inflammation, Adverse Events and Disease Progression
- ClinicalTrials.gov ID
- NCT04767685
- Acronym / sponsor ID
- BPBB / 041/09f
- Conditions
- Anesthesia, Surgical Procedure, Operative
- Keywords
- Genetic association study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 547 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | –Consenting patients undergoing non-emergency surgery with anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for non-emergency surgery
Key inclusion criteria (3 listed)
- 18 years and older
- Written informed consent
- Non-emergency surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 38379859Bello C, Filipovic MG, Huber M, Flannery S, Kobel B, Fischer R, Kessler BM, Raber L, Stueber F, Luedi MM. Discovery of plasma proteome markers associated with clinical outcome and immunological stress after cardiac surgery. Front Cardiovasc Med. 2023 Dec 22;10:1287724. doi: 10.3389/fcvm.2023.1287724. eCollection 2023.
- Derived from this study: PubMed 34831051Heinisch PP, Mihalj M, Huber M, Schefold JC, Hartmann A, Walter M, Steinhagen-Thiessen E, Schmidli J, Stuber F, Raber L, Luedi MM. Impact of Lipoprotein(a) Levels on Perioperative Outcomes in Cardiac Surgery. Cells. 2021 Oct 21;10(11):2829. doi: 10.3390/cells10112829.
Related trials for Anesthesia
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
Not yet recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
Active, not recruiting
Comparison of Prophylactic Continuous Infusion of Norepinephrine, Ephedrine, and Their Combination for Prevention of Hypotension During Spinal Anaesthesia for Caesarean Delivery
Maternal Hypotension After Spinal Anesthesia
RecruitingPhase 4
The Electroencephalographic Mechanisms of Anesthesia and Human Consciousness
Consciousness, Level Altered
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Stüber, Prof. MD study chair
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Markus M Lüdi, MD study director
Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Surgical Procedure, Operative, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change of the metabolic profile in the perioperative setting (time frame: Before induction of anesthesia as baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767685, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.