Perioperative Depression, an Observational Cohort Study

NCT06783842 | Active Not Recruiting

• 1 other identifier: 2024-01664-01 Periopdepr
• Study Type: observational
• Target: 700,000
• Locations: 1 country
• Sites: 1

Brief Summary

This observational cohort study studies two aspects of perioperative depression. First, it examines the postoperative morbidity and mortality among patients with preoperative depression. Secondly, in a subset of patients without signs of preoperative depression, the investigators describe the riskfactors for development of de-novo postoperative depression.

Conditions

Surgery With General Anesthesia; Depression - Major Depressive Disorder

Keywords

Perioperative medicine; Perioperative depression; Observational study

Outcome Measures

Primary Outcomes (2)

• Mortality

  Death after index surgery, time frames (see below)

  30/60/90/365-day mortality

• Days At Home Alive at 30 days after surgery

  DAH-30 is calculated using mortality and hospitalisation data from the date of the index surgery (= Day 0). For example, if a patient died on day 2 after their surgery whilst still an inpatient, they would be assigned zero (0) days at home; if a patient was discharged from hospital on Day 6 after surgery but was subsequently re-admitted for 4 days before their second hospital discharge, then they would be assigned a DAH-30 value of 20. If a patient has complications and spends 16 days in hospital, and then is transferred to a nursing facility for rehabilitation, and spend 24 days there before finally being discharged to their own home, they would be assigned a DAH-30 value of zero (0), even though 30-16-24 = -10 because the minimum value of DAH-30 should be zero. If a patient dies within 30 days of surgery, irrespective of whether they have spent some time at home, DAH-30 will be scored as zero (0). That is, DAH-30 captures the impact of any complications after surgery.

  30 days

Study Arms (1)

Surgical cohort

Adult patients undergoing surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This cohort is fully comprised of adult patients undergoing surgery at Karolinska University Hospital in Solna or in Huddinge

You may qualify if:

• \*Adult patients (18 years or older) undergoing surgery at Karolinska University Hospital in Solna or in Huddinge

You may not qualify if:

• \*Patients under the age of 18.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, 17176, Sweden

Location

Related Publications (16)

• Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015 Apr 27;385 Suppl 2:S11. doi: 10.1016/S0140-6736(15)60806-6. Epub 2015 Apr 26.

  PMID: 26313057 RESULT

• Prowle JR, Forni LG, Bell M, Chew MS, Edwards M, Grams ME, Grocott MPW, Liu KD, McIlroy D, Murray PT, Ostermann M, Zarbock A, Bagshaw SM, Bartz R, Bell S, Bihorac A, Gan TJ, Hobson CE, Joannidis M, Koyner JL, Levett DZH, Mehta RL, Miller TE, Mythen MG, Nadim MK, Pearse RM, Rimmele T, Ronco C, Shaw AD, Kellum JA. Postoperative acute kidney injury in adult non-cardiac surgery: joint consensus report of the Acute Disease Quality Initiative and PeriOperative Quality Initiative. Nat Rev Nephrol. 2021 Sep;17(9):605-618. doi: 10.1038/s41581-021-00418-2. Epub 2021 May 11.

  PMID: 33976395 RESULT

• Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.

  PMID: 27829093 RESULT

• Platzbecker K, Grabitz SD, Raub D, Rudolph MI, Friedrich S, Vinzant N, Kurth T, Weimar C, Bhatt DL, Nozari A, Houle TT, Xu X, Eikermann M. Development and external validation of a prognostic model for ischaemic stroke after surgery. Br J Anaesth. 2021 Nov;127(5):713-721. doi: 10.1016/j.bja.2021.05.035. Epub 2021 Jul 22.

  PMID: 34303492 RESULT

• Bell M, Eriksson LI, Svensson T, Hallqvist L, Granath F, Reilly J, Myles PS. Days at Home after Surgery: An Integrated and Efficient Outcome Measure for Clinical Trials and Quality Assurance. EClinicalMedicine. 2019 Apr 27;11:18-26. doi: 10.1016/j.eclinm.2019.04.011. eCollection 2019 May-Jun.

  PMID: 31317130 RESULT

• Grocott MP, Pearse RM. Prognostic studies of perioperative risk: robust methodology is needed. Br J Anaesth. 2010 Sep;105(3):243-5. doi: 10.1093/bja/aeq207. No abstract available.

  PMID: 20716567 RESULT

• Thurin E, Ryden I, Skoglund T, Smits A, Gulati S, Hesselager G, Bartek J Jr, Henriksson R, Salvesen O, Jakola AS. Impact of meningioma surgery on use of antiepileptic, antidepressant, and sedative drugs: A Swedish nationwide matched cohort study. Cancer Med. 2021 May;10(9):2967-2977. doi: 10.1002/cam4.3868. Epub 2021 Mar 26.

  PMID: 33773085 RESULT

• Ryden I, Thurin E, Carstam L, Smits A, Gulati S, Henriksson R, Salvesen O, Store Jakola A. Psychotropic and anti-epileptic drug use, before and after surgery, among patients with low-grade glioma: a nationwide matched cohort study. BMC Cancer. 2021 Mar 8;21(1):248. doi: 10.1186/s12885-021-07939-w.

  PMID: 33685410 RESULT

• Thurin E, Forander P, Bartek J Jr, Gulati S, Ryden I, Smits A, Hesselager G, Salvesen O, Jakola AS. Depression and ability to work after vestibular schwannoma surgery: a nationwide registry-based matched cohort study on antidepressants, sedatives, and sick leave. Acta Neurochir (Wien). 2021 Aug;163(8):2225-2235. doi: 10.1007/s00701-021-04862-8. Epub 2021 May 7.

  PMID: 33963435 RESULT

• Wilson BR, Tringale KR, Hirshman BR, Zhou T, Umlauf A, Taylor WR, Ciacci JD, Carter BS, Chen CC. Depression After Spinal Surgery: A Comparative Analysis of the California Outcomes Database. Mayo Clin Proc. 2017 Jan;92(1):88-97. doi: 10.1016/j.mayocp.2016.06.030. Epub 2016 Nov 9.

  PMID: 27836112 RESULT

• Menard C, Hodes GE, Russo SJ. Pathogenesis of depression: Insights from human and rodent studies. Neuroscience. 2016 May 3;321:138-162. doi: 10.1016/j.neuroscience.2015.05.053. Epub 2015 May 30.

  PMID: 26037806 RESULT

• Wancata J, Windhaber J, Bach M, Meise U. Recognition of psychiatric disorders in nonpsychiatric hospital wards. J Psychosom Res. 2000 Feb;48(2):149-55. doi: 10.1016/s0022-3999(99)00098-7.

  PMID: 10719131 RESULT

• Eaton WW, Shao H, Nestadt G, Lee HB, Bienvenu OJ, Zandi P. Population-based study of first onset and chronicity in major depressive disorder. Arch Gen Psychiatry. 2008 May;65(5):513-20. doi: 10.1001/archpsyc.65.5.513.

  PMID: 18458203 RESULT

• Mueller TI, Leon AC, Keller MB, Solomon DA, Endicott J, Coryell W, Warshaw M, Maser JD. Recurrence after recovery from major depressive disorder during 15 years of observational follow-up. Am J Psychiatry. 1999 Jul;156(7):1000-6. doi: 10.1176/ajp.156.7.1000.

  PMID: 10401442 RESULT

• Ormel J, Petukhova M, Chatterji S, Aguilar-Gaxiola S, Alonso J, Angermeyer MC, Bromet EJ, Burger H, Demyttenaere K, de Girolamo G, Haro JM, Hwang I, Karam E, Kawakami N, Lepine JP, Medina-Mora ME, Posada-Villa J, Sampson N, Scott K, Ustun TB, Von Korff M, Williams DR, Zhang M, Kessler RC. Disability and treatment of specific mental and physical disorders across the world. Br J Psychiatry. 2008 May;192(5):368-75. doi: 10.1192/bjp.bp.107.039107.

  PMID: 18450663 RESULT

• Rajan S, McKee M, Rangarajan S, Bangdiwala S, Rosengren A, Gupta R, Kutty VR, Wielgosz A, Lear S, AlHabib KF, Co HU, Lopez-Jaramillo P, Avezum A, Seron P, Oguz A, Kruger IM, Diaz R, Nafiza MN, Chifamba J, Yeates K, Kelishadi R, Sharief WM, Szuba A, Khatib R, Rahman O, Iqbal R, Bo H, Yibing Z, Wei L, Yusuf S; Prospective Urban Rural Epidemiology (PURE) Study Investigators. Association of Symptoms of Depression With Cardiovascular Disease and Mortality in Low-, Middle-, and High-Income Countries. JAMA Psychiatry. 2020 Oct 1;77(10):1052-1063. doi: 10.1001/jamapsychiatry.2020.1351.

  PMID: 32520341 RESULT

Study Officials

• Max Bell, MD, Phd

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Senior Lecturer

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

SE (1)