NCT03489486

Brief Summary

Multicentre international prospective cohort study designed to evaluate whether preoperative presepsin (sCD14-ST) is associated with the composite endpoint: all-cause mortality and major adverse cardiovascular or cerebrovascular events (MACCE) after elevated risk non-cardiac surgery. If so:

  1. 1.What is the optimal cut-off for presepsin to predict the composite endpoint all-cause mortality and MACCE?
  2. 2.Does the calculated optimal cut-off improve prediction of the composite endpoint all-cause mortality and MACCE when added to clinical data and established biomarkers?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,695

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 29, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

March 29, 2018

Last Update Submit

September 22, 2018

Conditions

Non Cardiac Surgery

Keywords

PresepsinsCD14-STbiomarkerperioperative risk

Outcome Measures

Primary Outcomes (1)

  • Composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke

    Number of Patients with Composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke

    at discharge or at day 30 after surgery (whatever comes first)

Secondary Outcomes (12)

  • Composite of intra- and postoperative in hospital all-cause mortality, non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care ≥24h and stroke

    30 days

  • All-cause mortality

    30 days

  • Non-fatal cardiac arrest

    30 days

  • Myocardial infarction

    30 days

  • Congestive heart failure requiring transfer to a higher unit of care or prolonging stay on ICU/intermediate care (≥24h)

    30 days

  • +7 more secondary outcomes

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing elective, elevated-risk noncardiac surgery.

You may qualify if:

  • Enrollment in MET-REPAIR (NCT03016936)
  • Signed written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesiology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

Related Publications (6)

  • Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

    PMID: 22998715BACKGROUND

  • Devereaux PJ, Mrkobrada M, Sessler DI, Leslie K, Alonso-Coello P, Kurz A, Villar JC, Sigamani A, Biccard BM, Meyhoff CS, Parlow JL, Guyatt G, Robinson A, Garg AX, Rodseth RN, Botto F, Lurati Buse G, Xavier D, Chan MT, Tiboni M, Cook D, Kumar PA, Forget P, Malaga G, Fleischmann E, Amir M, Eikelboom J, Mizera R, Torres D, Wang CY, VanHelder T, Paniagua P, Berwanger O, Srinathan S, Graham M, Pasin L, Le Manach Y, Gao P, Pogue J, Whitlock R, Lamy A, Kearon C, Baigent C, Chow C, Pettit S, Chrolavicius S, Yusuf S; POISE-2 Investigators. Aspirin in patients undergoing noncardiac surgery. N Engl J Med. 2014 Apr 17;370(16):1494-503. doi: 10.1056/NEJMoa1401105. Epub 2014 Mar 31.

    PMID: 24679062BACKGROUND

  • Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, De Hert S, Ford I, Gonzalez Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luescher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Uva MS, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur J Anaesthesiol. 2014 Oct;31(10):517-73. doi: 10.1097/EJA.0000000000000150. No abstract available.

    PMID: 25127426BACKGROUND

  • Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN; American College of Cardiology; American Heart Association. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014 Dec 9;64(22):e77-137. doi: 10.1016/j.jacc.2014.07.944. Epub 2014 Aug 1. No abstract available.

    PMID: 25091544BACKGROUND

  • Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA, Cook EF, Sugarbaker DJ, Donaldson MC, Poss R, Ho KK, Ludwig LE, Pedan A, Goldman L. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation. 1999 Sep 7;100(10):1043-9. doi: 10.1161/01.cir.100.10.1043.

    PMID: 10477528BACKGROUND

  • Gupta PK, Gupta H, Sundaram A, Kaushik M, Fang X, Miller WJ, Esterbrooks DJ, Hunter CB, Pipinos II, Johanning JM, Lynch TG, Forse RA, Mohiuddin SM, Mooss AN. Development and validation of a risk calculator for prediction of cardiac risk after surgery. Circulation. 2011 Jul 26;124(4):381-7. doi: 10.1161/CIRCULATIONAHA.110.015701. Epub 2011 Jul 5.

    PMID: 21730309BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

Study Officials

  • Jan Larmann, MD/PhD

    Department of Anesthesiology, Univeristy Hospital Heidelberg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jan Larmann, MD/PhD

CONTACT

+49 6221 56jan.larmann@med.uni-heidelberg.de

Florian Espeter, MD

CONTACT

+49 6221 56florian.espeter@med.uni-heidelberg.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., PhD

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 5, 2018

Study Start

June 15, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

September 25, 2018

Record last verified: 2018-09

Locations

DE(1)