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Critical IllnessEGAP-ICUNCT05513456

Ethnic and Gender Based Admittance Patterns in the ICU

An observational study of Critical Illness and Gender Equality, run by Karolinska Institutet at 1 site in Sweden.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Randomization to a different factors in the case descriptions
How many people
5,000 participants
Where
1 siteSweden
Study dates
31 May 2024to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sweden1 site, 1 recruiting
  • Karolinska Institutet

    Stockholm

    Max Bell, MD, PhD, max.bell@regionstockholm.se

    Max Bell, MD, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: Ethnic and Gender Based Admittance Patterns in the ICU, a Multicenter, International Randomized Survey Study

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.

Read more

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.

Read the detailed description

Background Differing treatment of men and women in several fields of health care is receiving growing attention. This includes care of the critically ill, as awareness of intensive care has dramatically increased during the last years. Critically ill patients are treated in Intensive Care Units (ICU), one of the most expensive and advanced types of care. It is therefore essential that resources are adequately used so that the patient most in need is selected for intensive care, but also that no patient in need is left without.

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. It has also been shown that women and men with severe sepsis receive differential care in the emergency department. These differences do not unambiguously translate into a survival benefit for men; studies show conflicting results. One could only speculate if survival figures would be altered if women were admitted to ICU in the same extent. Sex is a biological variable that affects the immune system and changes throughout life. It is proposed that sex hormones have an impact on how the severity of an illness progresses, where female sex hormones are suggested to have a protective effect. This could partly explain male dominance in the ICU. There is no clear evidence that care given in the ICU should be tailored after the sex of the patient. Then again, there is no clear evidence that the medical care should not be tailored after the sex of the patient. Differing care provided to men and women is therefore controversial. If differences exist, it must be ruled out that it is caused by gender bias, unintentional or not.

As discussed in a recently published Guidance on Reporting of Race and Ethnicity in Medical and Science Journals, Ethnicity are social constructs, without scientific or biological meaning. However, studies including ethnicity may be useful to improve understanding and knowledge of disparities and inequities in health care. Three decades ago, US Department of Health and Human Services published a report on Black and minority health, highlighting ethnic differences. (S Department of Health and Human Services. Report of the Secretary's Task Force on Black and Minority Health. 1985. https://collections.nlm.nih.gov/catalog/nlm:nlmuid-8602912-mvset). Whilst recent studies show reductions in racial and ethnic differences in self-reported health status and health care access and affordability, variances persist. During the COVID-19 pandemic it has become apparent that differences in progression to severe disease exist. In a cohort study using the OpenSAFELY platform in England, including more than 17 million adults, some minority ethnic populations had increased risk of severe COVID-19 as compared with the White population, also after taking other factors of importance into account.

Specific aims When admitting patients to our ICUs, do clinicians discriminate against certain ethnicities? Are thresholds for admitting men lower than for women? The investigators hypothesize that differing ICU admission thresholds exist, due to non-medical reasons.

Method The investigators propose testing this hypothesis using a blinded randomized factorial survey study.

This survey will consist of multiple iterations of eight separate cases, describing a patient in the ward or in the emergency room that may need ICU admission. Co-morbid data, age, physiological parameters will be described followed by a YES/NO: would you admit this patient to your ICU, considering a "normal" ICU situation in your hospital. A count-down timer for each case will ensure that the YES/NO response comes quickly, and whilst a paper case can never mimic a real clinical situation, making fast decisions is a part of how intensivists work.

The factors affecting ICU admission are usually considered to be 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.

In order to test if gender and/or ethnicity affects ICU admission the survey will be randomized in several ways. Essentially, multiple different versions of the survey will exist. We will tweak the age and number of co-morbid conditions described. It is likely, but not certain, that higher patient age and more co-morbid conditions will be associated will lower admission rates. The same association is expected during a theoretical pandemic situation, with strained resources.

Unbeknown to the respondents, the cases will be randomized to describe a man or a woman. Thus, the cases can be in the order of Male, Female, M, F or reversed: F,M,F,M and so on. In one of the eight cases, the name of the patient will be a non-typical national name.

To make this generalizable and overall successful, the investigators think it is paramount to have the survey translated to French, German, Spanish and to make it simple to answer. Preferably the survey should take less than 10 minutes to complete. Moreover, sending emails, through the national organizations, might improve generalizability. Using a survey link, for instance via twitter, could create a selection bias in who chooses to click on such a link.

(This research group has done this before, so it can be done. Luckily for this project, it is not a widely cited study. https://www.nature.com/articles/s41598-019-50836-3 )

Being tested
Randomization to a different factors in the case descriptions
Medical subject headings
Critical Illness, Sexism, Racism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Randomization to a different factors in the case descriptionsBehavioural

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ratio of ICU admission men vs women

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

    Measured: Through study completion, an average of 1 year

  2. Ratio of ICU admission ethnic background

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

    Measured: Through study completion, an average of 1 year

Secondary outcomes (4)
  1. Time to ICU admission men vs women

    Do respondents take longer to decide to admit women compared to men?

    Measured: Through study completion, an average of 1 year

  2. Time to ICU admission ethnic background

    Do respondents take longer to decide to admit descriptions of patients with "other" ethnic background compared to "normal" ethnic background?

    Measured: Through study completion, an average of 1 year

  3. Time-out sex/gender

    Do respondents more often run out of time in thinking about admitting women compared to men?

    Measured: Through study completion, an average of 1 year

  4. Time-out described ethnicity

    Do respondents more often run out of time in thinking about admitting descriptions of patients with "other" ethnic background compared to "normal" ethnic background?

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2022
  2. Study start31 May 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05513456
Sponsor's protocol ID
EGAP-ICU Project Implicit
Acronym
EGAP-ICU
Status last verified
Aug 2026
First submitted
22 Aug 2022
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 22617003
  • 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.

    PubMed 12847381
  • 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.

    PubMed 18003954
  • 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.

    PubMed 25887421
  • 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.

    PubMed 31974918
  • 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.

    PubMed 31683118
  • 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.

    PubMed 11753049
  • 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.

    PubMed 11066139
  • 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.

    PubMed 34402850
  • 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.

    PubMed 34402830
  • 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.

    PubMed 33939953

Questions about this trial

What is this clinical trial studying?

An observational study of Critical Illness and Gender Equality, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Max Bell, MD, PhD (+46708278533, max.bell@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio of ICU admission men vs women (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05513456, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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