NCT05513456

Brief Summary

The dominating proportion of patients in the ICU are men. Studies indicate that men receive more mechanical ventilation, vasoactive drugs, renal replacement therapy, invasive monitoring and have longer length of stay in the ICU. These differences do not unambiguously translate into a survival benefit for men; if survival would be altered if women were admitted to ICU in the same extent is unknown. Factors affecting ICU admission include age, co-morbidities, physiological parameters (indicating severity of the acute illness) and, additionally, the number of available ICU beds. Factors that should not affect ICU admission include patient gender or ethnicity. This study aims at studying if bias against women and people of certain ethnicities exist. Do clinicians have differing thresholds for ICU admission due to non-medical reasons? The investigators propose testing this hypothesis using a blinded randomized factorial survey study.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress80%
May 2024Nov 2026

First Submitted

Initial submission to the registry

August 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2022

Completed
1.8 years until next milestone

Study Start

First participant enrolled

May 31, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

August 22, 2022

Last Update Submit

August 26, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Ratio of ICU admission men vs women

    Exact same case descriptions except for the fact that the sex/gender is randomized

    Through study completion, an average of 1 year

  • Ratio of ICU admission ethnic background

    Exact same case descriptions except for the fact that the name/ethnic background is randomized

    Through study completion, an average of 1 year

Secondary Outcomes (4)

  • Time to ICU admission men vs women

    Through study completion, an average of 1 year

  • Time to ICU admission ethnic background

    Through study completion, an average of 1 year

  • Time-out sex/gender

    Through study completion, an average of 1 year

  • Time-out described ethnicity

    Through study completion, an average of 1 year

Interventions

The case descriptions will include factors like age, co-morbid status and acute physiological parameters; but the factor of sex/gender will be randomized. Moreover, randomization to case description of typical vs non-typical national name will be done.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive care physicians and other physicians working with admission (or non-admission) of critically ill patients across the world are eligible to participate in the study.

You may qualify if:

  • We will include intensive care physicians, both in training and specialists as responders in this randomized survey study

You may not qualify if:

  • We will exclude "button-mashers", i.e. participating respondents that toggle through the case descriptions faster than they possibly could read the case description. A case answered \<20 seconds will be ruled out.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

RECRUITING

Related Publications (11)

  • Mahmood K, Eldeirawi K, Wahidi MM. Association of gender with outcomes in critically ill patients. Crit Care. 2012 May 22;16(3):R92. doi: 10.1186/cc11355.

    PMID: 22617003BACKGROUND
  • Valentin A, Jordan B, Lang T, Hiesmayr M, Metnitz PG. Gender-related differences in intensive care: a multiple-center cohort study of therapeutic interventions and outcome in critically ill patients. Crit Care Med. 2003 Jul;31(7):1901-7. doi: 10.1097/01.CCM.0000069347.78151.50.

    PMID: 12847381BACKGROUND
  • Fowler RA, Sabur N, Li P, Juurlink DN, Pinto R, Hladunewich MA, Adhikari NK, Sibbald WJ, Martin CM. Sex-and age-based differences in the delivery and outcomes of critical care. CMAJ. 2007 Dec 4;177(12):1513-9. doi: 10.1503/cmaj.071112. Epub 2007 Nov 14.

    PMID: 18003954BACKGROUND
  • Samuelsson C, Sjoberg F, Karlstrom G, Nolin T, Walther SM. Gender differences in outcome and use of resources do exist in Swedish intensive care, but to no advantage for women of premenopausal age. Crit Care. 2015 Mar 30;19(1):129. doi: 10.1186/s13054-015-0873-1.

    PMID: 25887421BACKGROUND
  • Sunden-Cullberg J, Nilsson A, Inghammar M. Sex-based differences in ED management of critically ill patients with sepsis: a nationwide cohort study. Intensive Care Med. 2020 Apr;46(4):727-736. doi: 10.1007/s00134-019-05910-9. Epub 2020 Jan 23.

    PMID: 31974918BACKGROUND
  • Zettersten E, Jaderling G, Bell M, Larsson E. Sex and gender aspects on intensive care. A cohort study. J Crit Care. 2020 Feb;55:22-27. doi: 10.1016/j.jcrc.2019.09.023. Epub 2019 Oct 25.

    PMID: 31683118BACKGROUND
  • Knoferl MW, Angele MK, Diodato MD, Schwacha MG, Ayala A, Cioffi WG, Bland KI, Chaudry IH. Female sex hormones regulate macrophage function after trauma-hemorrhage and prevent increased death rate from subsequent sepsis. Ann Surg. 2002 Jan;235(1):105-12. doi: 10.1097/00000658-200201000-00014.

    PMID: 11753049BACKGROUND
  • Mizushima Y, Wang P, Jarrar D, Cioffi WG, Bland KI, Chaudry IH. Estradiol administration after trauma-hemorrhage improves cardiovascular and hepatocellular functions in male animals. Ann Surg. 2000 Nov;232(5):673-9. doi: 10.1097/00000658-200011000-00009.

    PMID: 11066139BACKGROUND
  • Flanagin A, Frey T, Christiansen SL; AMA Manual of Style Committee. Updated Guidance on the Reporting of Race and Ethnicity in Medical and Science Journals. JAMA. 2021 Aug 17;326(7):621-627. doi: 10.1001/jama.2021.13304. No abstract available.

    PMID: 34402850BACKGROUND
  • Mahajan S, Caraballo C, Lu Y, Valero-Elizondo J, Massey D, Annapureddy AR, Roy B, Riley C, Murugiah K, Onuma O, Nunez-Smith M, Forman HP, Nasir K, Herrin J, Krumholz HM. Trends in Differences in Health Status and Health Care Access and Affordability by Race and Ethnicity in the United States, 1999-2018. JAMA. 2021 Aug 17;326(7):637-648. doi: 10.1001/jama.2021.9907.

    PMID: 34402830BACKGROUND
  • Mathur R, Rentsch CT, Morton CE, Hulme WJ, Schultze A, MacKenna B, Eggo RM, Bhaskaran K, Wong AYS, Williamson EJ, Forbes H, Wing K, McDonald HI, Bates C, Bacon S, Walker AJ, Evans D, Inglesby P, Mehrkar A, Curtis HJ, DeVito NJ, Croker R, Drysdale H, Cockburn J, Parry J, Hester F, Harper S, Douglas IJ, Tomlinson L, Evans SJW, Grieve R, Harrison D, Rowan K, Khunti K, Chaturvedi N, Smeeth L, Goldacre B; OpenSAFELY Collaborative. Ethnic differences in SARS-CoV-2 infection and COVID-19-related hospitalisation, intensive care unit admission, and death in 17 million adults in England: an observational cohort study using the OpenSAFELY platform. Lancet. 2021 May 8;397(10286):1711-1724. doi: 10.1016/S0140-6736(21)00634-6. Epub 2021 Apr 30.

    PMID: 33939953BACKGROUND

MeSH Terms

Conditions

Critical IllnessSexismRacism

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Officials

  • Max Bell, MD, PhD

    Department of Physiology and Pharmacology, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 24, 2022

Study Start

May 31, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

The IPD consists of respondent country, respondent sex (M/F/other), size of hospital (university vs non-university hospital), specialist/in training, respondent age group in brackets of 10. It is paramount that the physicians responding to this survey know that we will not collect precise individual data, nor share the block data we do collect.

Locations