Cohort Profile of BIGPROMISE: a Perioperative Biobank of a High-risk Surgical Population

Overview

Journal BMJ Open

Specialty General Medicine

Date 2024 Jun 11

PMID 38862228

Authors

Peter G Noordzij

Henk Jt Ruven

Ted Reniers

Rene N Idema

Maaike Sy Thio

Olaf L Cremer

Nynke Hollema

Kyra N Smit

Lisette M Vernooij

Ineke M Dijkstra

Thijs Cd Rettig

Affiliations

Soon will be listed here.

Abstract

Purpose: Postoperative complications increase mortality, disability and costs. Advanced understanding of the risk factors for postoperative complications is needed to improve surgical outcomes. This paper discusses the rationale and profile of the BIGPROMISE (biomarkers to guide perioperative management and improve outcome in high-risk surgery) cohort, that aims to investigate risk factors, pathophysiology and outcomes related to postoperative complications.

Participants: Adult patients undergoing major surgery in two tertiary teaching hospitals. Clinical data and blood samples are collected before surgery, at the end of surgery and on the first, second and third postoperative day. At each time point a panel of cardiovascular, inflammatory, renal, haematological and metabolic biomarkers is assessed. Aliquots of plasma, serum and whole blood of each time point are frozen and stored. Data on severe complications are prospectively collected during 30 days after surgery. Functional status is assessed before surgery and after 120 days using the WHO Disability Assessment Schedule (WHODAS) 2.0. Mortality is followed up until 2 years after surgery.

Findings To Date: The first patient was enrolled on 8 October 2021. Currently (1 January 2024) 3086 patients were screened for eligibility, of whom 1750 (57%) provided informed consent for study participation. Median age was 66 years (60; 73), 28% were female, and 68% of all patients were American Society of Anaesthesiologists (ASA) physical status class 3. Most common types of major surgery were cardiac (49%) and gastro-intestinal procedures (26%). The overall incidence of 30-day severe postoperative complications was 16%.

Future Plans: By the end of the recruitment phase, expected in 2026, approximately 3000 patients with major surgery will have been enrolled. This cohort allows us to investigate the role of pathophysiological perioperative processes in the cause of postoperative complications, and to discover and develop new biomarkers to improve risk stratification for adverse postoperative outcomes.

Trial Registration Number: NCT05199025.

References

Khuri S, Henderson W, DePalma R, Mosca C, Healey N, Kumbhani D . Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg. 2005; 242(3):326-41. PMC: 1357741. DOI: 10.1097/01.sla.0000179621.33268.83. View

Verwijmeren L, Noordzij P, Daeter E, Emmelot-Vonk M, Vernooij L, van Klei W . Preoperative frailty and one-year functional recovery in elderly cardiac surgery patients. J Thorac Cardiovasc Surg. 2022; 166(3):870-878.e6. DOI: 10.1016/j.jtcvs.2022.01.032. View

Lurati Buse G, Pinto B, Abelha F, Abbott T, Ackland G, Afshari A . ESAIC focused guideline for the use of cardiac biomarkers in perioperative risk evaluation. Eur J Anaesthesiol. 2023; 40(12):888-927. DOI: 10.1097/EJA.0000000000001865. View

Riley R, Snell K, Ensor J, Burke D, Harrell Jr F, Moons K . Minimum sample size for developing a multivariable prediction model: PART II - binary and time-to-event outcomes. Stat Med. 2018; 38(7):1276-1296. PMC: 6519266. DOI: 10.1002/sim.7992. View

Dindo D, Demartines N, Clavien P . Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004; 240(2):205-13. PMC: 1360123. DOI: 10.1097/01.sla.0000133083.54934.ae. View

Ackland G, Abbott T, Cain D, Edwards M, Sultan P, Karmali S . Preoperative systemic inflammation and perioperative myocardial injury: prospective observational multicentre cohort study of patients undergoing non-cardiac surgery. Br J Anaesth. 2019; 122(2):180-187. PMC: 6354048. DOI: 10.1016/j.bja.2018.09.002. View

Rettig T, Verwijmeren L, Dijkstra I, Boerma D, van de Garde E, Noordzij P . Postoperative Interleukin-6 Level and Early Detection of Complications After Elective Major Abdominal Surgery. Ann Surg. 2015; 263(6):1207-12. DOI: 10.1097/SLA.0000000000001342. View

Castellheim A, Brekke O, Espevik T, HARBOE M, Mollnes T . Innate immune responses to danger signals in systemic inflammatory response syndrome and sepsis. Scand J Immunol. 2009; 69(6):479-91. DOI: 10.1111/j.1365-3083.2009.02255.x. View

Weiser T, Haynes A, Molina G, Lipsitz S, Esquivel M, Uribe-Leitz T . Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015; 385 Suppl 2:S11. DOI: 10.1016/S0140-6736(15)60806-6. View

10.

Devereaux P, Biccard B, Sigamani A, Xavier D, Chan M, Srinathan S . Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017; 317(16):1642-1651. DOI: 10.1001/jama.2017.4360. View

11.

Vonlanthen R, Slankamenac K, Breitenstein S, Puhan M, Muller M, Hahnloser D . The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients. Ann Surg. 2011; 254(6):907-13. DOI: 10.1097/SLA.0b013e31821d4a43. View

12.

Paun B, Cassie S, MacLean A, Dixon E, Buie W . Postoperative complications following surgery for rectal cancer. Ann Surg. 2010; 251(5):807-18. DOI: 10.1097/SLA.0b013e3181dae4ed. View

13.

Crawford T, Magruder J, Grimm J, Suarez-Pierre A, Sciortino C, Mandal K . Complications After Cardiac Operations: All Are Not Created Equal. Ann Thorac Surg. 2016; 103(1):32-40. DOI: 10.1016/j.athoracsur.2016.10.022. View

14.

. Global patient outcomes after elective surgery: prospective cohort study in 27 low-, middle- and high-income countries. Br J Anaesth. 2016; 117(5):601-609. PMC: 5091334. DOI: 10.1093/bja/aew316. View

15.

Paul S, Sedrakyan A, Chiu Y, Nasar A, Port J, Lee P . Outcomes after lobectomy using thoracoscopy vs thoracotomy: a comparative effectiveness analysis utilizing the Nationwide Inpatient Sample database. Eur J Cardiothorac Surg. 2012; 43(4):813-7. DOI: 10.1093/ejcts/ezs428. View

16.

Siontis K, Siontis G, Contopoulos-Ioannidis D, Ioannidis J . Diagnostic tests often fail to lead to changes in patient outcomes. J Clin Epidemiol. 2014; 67(6):612-21. DOI: 10.1016/j.jclinepi.2013.12.008. View

17.

Archer S, Pinto A, Vuik S, Bicknell C, Faiz O, Byrne B . Surgery, Complications, and Quality of Life: A Longitudinal Cohort Study Exploring the Role of Psychosocial Factors. Ann Surg. 2018; 270(1):95-101. DOI: 10.1097/SLA.0000000000002745. View

18.

Turan A, Artis A, Hanline C, Saha P, Maheshwari K, Kurz A . Preoperative Vitamin D Concentration and Cardiac, Renal, and Infectious Morbidity after Noncardiac Surgery. Anesthesiology. 2019; 132(1):121-130. DOI: 10.1097/ALN.0000000000003000. View

19.

Rossler J, Schoenrath F, Seifert B, Kaserer A, Spahn G, Falk V . Iron deficiency is associated with higher mortality in patients undergoing cardiac surgery: a prospective study. Br J Anaesth. 2019; 124(1):25-34. DOI: 10.1016/j.bja.2019.09.016. View

20.

Bain C, Myles P, Corcoran T, Dieleman J . Postoperative systemic inflammatory dysregulation and corticosteroids: a narrative review. Anaesthesia. 2022; 78(3):356-370. PMC: 10092416. DOI: 10.1111/anae.15896. View