NCT04767685

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
547

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 23, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

10.9 years

First QC Date

December 16, 2020

Last Update Submit

November 14, 2022

Conditions

Keywords

Genetic association study

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    On postoperative day 1 during the morning round between 07:30-9:00am

Study Arms (1)

All patients

Consenting patients undergoing non-emergency surgery with anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for non-emergency surgery

You may qualify if:

  • years and older
  • Written informed consent
  • Non-emergency surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

Bern, 3010, Switzerland

Location

Related Publications (2)

  • 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.

  • Heinisch 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.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (plasma and cells)

Study Officials

  • Frank Stüber, Prof. MD

    Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

    STUDY CHAIR
  • Markus M Lüdi, MD

    Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2020

First Posted

February 23, 2021

Study Start

January 1, 2011

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

November 15, 2022

Record last verified: 2022-11

Locations