Intensive Care (ICU)NCT07768410
Supply Induced Demand in Intensive Care Unit: a Retrospective Trial
An observational study of Intensive Care (ICU) and Intensive Care Unit (ICU) Admission, run by Saint Camillus International University of Health Sciences at 1 site in Italy.
Trial summary
Intensive Care Unit (ICU) represents a high-level healthcare and expensive resource in hospitals. The causes of hospitalization in critical care are therefore multiple, and over the years numerous prognostic scores have been proposed, which therefore correlate the severity of the pathology with the predicted mortality… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care (ICU), Intensive Care Unit (ICU) Admission, Intensive Care Unit Survivors
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 20 Aug 2026to 20 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Post-operative Intensive Care, St. Eugenio Hospital, Rome, Italy
Who may be able to join
- Patients admitted to the ICU from November 2018 to November 2025
Who cannot join
- Incomplete documentation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
St. Eugenio Hospital
Rome, 00144
Diego Fiume, 0039 0651002979, diego.fiume@unicamillus.org
Massimo Galletti, 0039 0651002979, massimo.galletti@aslroma2.it
About this study
Intensive Care Unit (ICU) represents a high-level healthcare and expensive resource in hospitals. The causes of hospitalization in critical care are therefore multiple, and over the years numerous prognostic scores have been proposed, which therefore correlate the severity of the pathology with the predicted mortality from a statistical point of view. The function of the scores is also to assist the physician in clinical choices. The two most frequently used prognostic scores in critical care are the Acute Physiology And Chronic Health Evaluation (APACHE) II score and the Simplified Acute Physiology Score (SAPS) II.
The choice to admit a patient to Intensive Care, therefore, is a clinical, economic and managerial choice. Due to the costs of the ICU beds, as well as to the fact that shortage of beds may have a significant clinical impact on patients, many studies addressed the issue of supply-induced scarcity (SIS), i.e. scarcity due to a lack of supply and not to an excess of demand. On the other side, Health Economics has demonstrated that often an increase in supply can generate an increase in demand, even when this increase is not strictly necessary or appropriate. This phenomenon, called supply-induced demand (SID), to the best of our knowledge, few studies have been conducted in critical care settings; moreover, the correlation between SID and outcomes, specifically mortality, has never been demonstrated.
The aim of this retrospective, single-center study, therefore, is to investigate the presence of SID, and the consequent effects on mortality outcome, in a multispecialty Postoperative Intensive Care Unit.
Read the detailed description
Intensive Care Unit (ICU) represents a high-level healthcare resource in hospitals. An ICU bed is expensive compared to other types of beds, estimated at between €937 and €1,472 each, according to studies in several European countries. The ICU is the department where the hospital's most seriously ill patients are treated. The nature of the hospitalization can vary, and each hospital has the option of having a multispecialty ICU (dedicated to all critically ill patients), or alternatively dedicated ICUs based on the primary pathology, such as cardiac surgery, neurosurgery, post-operative intensive care, transplant surgery, etc.
The causes of hospitalization in critical care are therefore multiple, and over the years numerous prognostic scores have been proposed, which therefore correlate the severity of the pathology with the predicted mortality from a statistical point of view. The function of the scores is also to assist the physician in clinical choices, helping to select patients who are presumed to have the greatest chance of benefiting from hospitalization in an intensive care environment, and therefore discarding patients who are either not too serious, or vice versa too compromised to benefit from hospitalization of this type. The long and difficult stay in Intensive Care can also influence the turnover of beds, and their availability.
The two most frequently used prognostic scores in critical care are the Acute Physiology And Chronic Health Evaluation (APACHE) II score and the Simplified Acute Physiology Score (SAPS) II. Both widely used in clinical and scientific settings, these scores present some differences: while the SAPS II has a more streamlined framework of the patient's clinical characteristics, the APACHE II considers a little more the anamnesis and chronic pathologies of the subject hospitalized in Intensive Care. In fact, the vital and physiological parameters addressed with the APACHE II are numerically higher than those of the SAPS II. Despite this, there does not appear to be a difference between the two scores in terms of predictive value of mortality; some studies have examined this hypothesis, finding both systems reliable from this point of view.
The choice to admit a patient to Intensive Care, therefore, is a clinical, economic and managerial choice. In recent years, several studies have examined the availability of beds in Intensive Care and their impact on the clinical and economic performance of the department. Sometimes the turnover is technically and temporally expensive due to numerous reasons, such as the severity of the clinical picture, the high level of monitoring and the number of connected machines, delaying the patient's admission. Several studies have noted how the waiting time before admission to Intensive Care increases patient mortality, especially when it is longer than 6 hours.
Due to the costs of the ICU beds, as well as to the fact that shortage of beds may have a significant clinical impact on patients, many studies addressed the issue of supply-induced scarcity (SIS), i.e. scarcity due to a lack of supply and not to an excess of demand.
In the case of beds in Intensive Care, some authors have demonstrated how the phenomenon of SIS affects the critical environment, but without alterations in the perception of value; for example, although the economic cost of a bed of this type is higher than in other departments, the cost/benefit ratio in terms of perception of the service provided remains positive for the patient and for the community. From 2020 onwards, following the Covid-19 pandemic, we have witnessed a profound revolution in the availability, number and type of triage that underlie the availability of beds in Intensive Care.
On the other side, Health Economics has demonstrated that often an increase in supply can generate an increase in demand, even when this increase is not strictly necessary or appropriate. This phenomenon, called supply-induced demand (SID), to the best of our knowledge, few studies have been conducted in critical care settings; moreover, the correlation between SID and outcomes, specifically mortality, has never been demonstrated.
The aim of this retrospective, single-center study, therefore, is to investigate the presence of SID, and the consequent effects on mortality outcome, in a multispecialty Postoperative Intensive Care Unit.
- Conditions
- Intensive Care (ICU), Intensive Care Unit (ICU) Admission, Intensive Care Unit Survivors, SID, Health and Social Services
- Keywords
- Intensive Care Unit, ICU, Intensive Care Unit Admission, Supply Induced Demand, SID
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to the post-operative intensive care unit | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of supply-induced demand for intensive care admission
Assess the patient's severity (APACHE II and SAPS II prognostic scores) based on the number of available beds at the time of admission
Measured: At enrollment
Secondary outcomes (1)
Mortality
Observe any potential correlation between SID and mortality incidence
Measured: From enrollment to the ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start20 Aug 2026 (estimated)
- Primary completion20 Sep 2026 (estimated)
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Intensive Care (ICU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Camillus International University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Fiume, Saint Camillus International University of Health Sciences
- Investigators
- Diego Fiume, Study chair, UniCamillus - Saint Camillus International University of Health and Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768410
- Sponsor's protocol ID
- 115.26
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share Individual Participant Data (IPD); however, anonymized data may be made available upon reasonable request, subject to sponsor approval and ethical considerations.
Publications
Robert R, Coudroy R, Ragot S, Lesieur O, Runge I, Souday V, Desachy A, Gouello JP, Hira M, Hamrouni M, Reignier J. Influence of ICU-bed availability on ICU admission decisions. Ann Intensive Care. 2015 Dec;5(1):55. doi: 10.1186/s13613-015-0099-z. Epub 2015 Dec 30.
PubMed 26714805Fuchs L, Novack V, McLennan S, Celi LA, Baumfeld Y, Park S, Howell MD, Talmor DS. Trends in severity of illness on ICU admission and mortality among the elderly. PLoS One. 2014 Apr 3;9(4):e93234. doi: 10.1371/journal.pone.0093234. eCollection 2014.
PubMed 24699251Barbash IJ, Wallace DJ, Kahn JM. Effects of Changes in ICU Bed Supply on ICU Utilization. Med Care. 2019 Jul;57(7):544-550. doi: 10.1097/MLR.0000000000001137.
PubMed 31107397Gooch RA, Kahn JM. ICU bed supply, utilization, and health care spending: an example of demand elasticity. JAMA. 2014 Feb 12;311(6):567-8. doi: 10.1001/jama.2013.283800. No abstract available.
PubMed 24408679Edbrooke DL, Minelli C, Mills GH, Iapichino G, Pezzi A, Corbella D, Jacobs P, Lippert A, Wiis J, Pesenti A, Patroniti N, Pirracchio R, Payen D, Gurman G, Bakker J, Kesecioglu J, Hargreaves C, Cohen SL, Baras M, Artigas A, Sprung CL. Implications of ICU triage decisions on patient mortality: a cost-effectiveness analysis. Crit Care. 2011;15(1):R56. doi: 10.1186/cc10029. Epub 2011 Feb 9.
PubMed 21306645Riccioni L, Bertolini G, Giannini A, Vergano M, Gristina G, Livigni S, Mistraletti G, Petrini Gruppo di Lavoro Siaarti-Societa Italiana di Anestesia Analgesia Rianimazione E Terapia Intensiva F. [Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances.]. Recenti Prog Med. 2020 Apr;111(4):207-211. doi: 10.1701/3347.33183. Italian.
PubMed 32319442Churpek MM, Wendlandt B, Zadravecz FJ, Adhikari R, Winslow C, Edelson DP. Association between intensive care unit transfer delay and hospital mortality: A multicenter investigation. J Hosp Med. 2016 Nov;11(11):757-762. doi: 10.1002/jhm.2630. Epub 2016 Jun 28.
PubMed 27352032Cardoso LT, Grion CM, Matsuo T, Anami EH, Kauss IA, Seko L, Bonametti AM. Impact of delayed admission to intensive care units on mortality of critically ill patients: a cohort study. Crit Care. 2011;15(1):R28. doi: 10.1186/cc9975. Epub 2011 Jan 18.
PubMed 21244671Chalfin DB, Trzeciak S, Likourezos A, Baumann BM, Dellinger RP; DELAY-ED study group. Impact of delayed transfer of critically ill patients from the emergency department to the intensive care unit. Crit Care Med. 2007 Jun;35(6):1477-83. doi: 10.1097/01.CCM.0000266585.74905.5A.
PubMed 17440421Mathews KS, Durst MS, Vargas-Torres C, Olson AD, Mazumdar M, Richardson LD. Effect of Emergency Department and ICU Occupancy on Admission Decisions and Outcomes for Critically Ill Patients. Crit Care Med. 2018 May;46(5):720-727. doi: 10.1097/CCM.0000000000002993.
PubMed 29384780Czajka S, Ziebinska K, Marczenko K, Posmyk B, Szczepanska AJ, Krzych LJ. Validation of APACHE II, APACHE III and SAPS II scores in in-hospital and one year mortality prediction in a mixed intensive care unit in Poland: a cohort study. BMC Anesthesiol. 2020 Dec 2;20(1):296. doi: 10.1186/s12871-020-01203-7.
PubMed 33267777Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957.
PubMed 8254858Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
PubMed 3928249Tan S, Martin J, Pezzi A, Bakker J, Neurohr C, Pitrelli A, Hakkaart L, Welte R. Microcosting study of ICU costs in three European countries. Crit Care 2008,12(Suppl 2):P526
Tan SS, Bakker J, Hoogendoorn ME, Kapila A, Martin J, Pezzi A, Pittoni G, Spronk PE, Welte R, Hakkaart-van Roijen L. Direct cost analysis of intensive care unit stay in four European countries: applying a standardized costing methodology. Value Health. 2012 Jan;15(1):81-6. doi: 10.1016/j.jval.2011.09.007.
PubMed 22264975
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supply Induced Demand in Intensive Care Unit: a Retrospective Trial
- ClinicalTrials.gov ID
- NCT07768410
- Acronym / sponsor ID
- 115.26
- Conditions
- Intensive Care (ICU), Intensive Care Unit (ICU) Admission, Intensive Care Unit Survivors, SID, Health and Social Services
- Keywords
- Intensive Care Unit, ICU, Intensive Care Unit Admission, Supply Induced Demand, SID
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Saint Camillus International University of Health SciencesUniversity, hospital or other
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 20 Sep 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intensive Care Unit (ICU) represents a high-level healthcare and expensive resource in hospitals. The causes of hospitalization in critical care are therefore multiple, and over the years numerous prognostic scores have been proposed, which therefore correlate the severity of the pathology with the predicted mortality from a statistical point of view. The function of the scores is also to assist the physician in clinical choices. The two most frequently used prognostic scores in critical care are the Acute Physiology And Chronic Health Evaluation (APACHE) II score and the Simplified Acute Physiology Score (SAPS) II.
The choice to admit a patient to Intensive Care, therefore, is a clinical, economic and managerial choice. Due to the costs of the ICU beds, as well as to the fact that shortage of beds may have a significant clinical impact on patients, many studies addressed the issue of supply-induced scarcity (SIS), i.e. scarcity due to a lack of supply and not to an excess of demand. On the other side, Health Economics has demonstrated that often an increase in supply can generate an increase in demand, even when this increase is not strictly necessary or appropriate. This phenomenon, called supply-induced demand (SID), to the best of our knowledge, few studies have been conducted in critical care settings; moreover, the correlation between SID and outcomes, specifically mortality, has never been demonstrated.
The aim of this retrospective, single-center study, therefore, is to investigate the presence of SID, and the consequent effects on mortality outcome, in a multispecialty Postoperative Intensive Care Unit.
Detailed description
Intensive Care Unit (ICU) represents a high-level healthcare resource in hospitals. An ICU bed is expensive compared to other types of beds, estimated at between €937 and €1,472 each, according to studies in several European countries. The ICU is the department where the hospital's most seriously ill patients are treated. The nature of the hospitalization can vary, and each hospital has the option of having a multispecialty ICU (dedicated to all critically ill patients), or alternatively dedicated ICUs based on the primary pathology, such as cardiac surgery, neurosurgery, post-operative intensive care, transplant surgery, etc.
The causes of hospitalization in critical care are therefore multiple, and over the years numerous prognostic scores have been proposed, which therefore correlate the severity of the pathology with the predicted mortality from a statistical point of view. The function of the scores is also to assist the physician in clinical choices, helping to select patients who are presumed to have the greatest chance of benefiting from hospitalization in an intensive care environment, and therefore discarding patients who are either not too serious, or vice versa too compromised to benefit from hospitalization of this type. The long and difficult stay in Intensive Care can also influence the turnover of beds, and their availability.
The two most frequently used prognostic scores in critical care are the Acute Physiology And Chronic Health Evaluation (APACHE) II score and the Simplified Acute Physiology Score (SAPS) II. Both widely used in clinical and scientific settings, these scores present some differences: while the SAPS II has a more streamlined framework of the patient's clinical characteristics, the APACHE II considers a little more the anamnesis and chronic pathologies of the subject hospitalized in Intensive Care. In fact, the vital and physiological parameters addressed with the APACHE II are numerically higher than those of the SAPS II. Despite this, there does not appear to be a difference between the two scores in terms of predictive value of mortality; some studies have examined this hypothesis, finding both systems reliable from this point of view.
The choice to admit a patient to Intensive Care, therefore, is a clinical, economic and managerial choice. In recent years, several studies have examined the availability of beds in Intensive Care and their impact on the clinical and economic performance of the department. Sometimes the turnover is technically and temporally expensive due to numerous reasons, such as the severity of the clinical picture, the high level of monitoring and the number of connected machines, delaying the patient's admission. Several studies have noted how the waiting time before admission to Intensive Care increases patient mortality, especially when it is longer than 6 hours.
Due to the costs of the ICU beds, as well as to the fact that shortage of beds may have a significant clinical impact on patients, many studies addressed the issue of supply-induced scarcity (SIS), i.e. scarcity due to a lack of supply and not to an excess of demand.
In the case of beds in Intensive Care, some authors have demonstrated how the phenomenon of SIS affects the critical environment, but without alterations in the perception of value; for example, although the economic cost of a bed of this type is higher than in other departments, the cost/benefit ratio in terms of perception of the service provided remains positive for the patient and for the community. From 2020 onwards, following the Covid-19 pandemic, we have witnessed a profound revolution in the availability, number and type of triage that underlie the availability of beds in Intensive Care.
On the other side, Health Economics has demonstrated that often an increase in supply can generate an increase in demand, even when this increase is not strictly necessary or appropriate. This phenomenon, called supply-induced demand (SID), to the best of our knowledge, few studies have been conducted in critical care settings; moreover, the correlation between SID and outcomes, specifically mortality, has never been demonstrated.
The aim of this retrospective, single-center study, therefore, is to investigate the presence of SID, and the consequent effects on mortality outcome, in a multispecialty Postoperative Intensive Care Unit.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients admitted to the post-operative intensive care unit | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Post-operative Intensive Care, St. Eugenio Hospital, Rome, Italy
Key inclusion criteria (1 listed)
- Patients admitted to the ICU from November 2018 to November 2025
Key exclusion criteria (1 listed)
- Incomplete documentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of supply-induced demand for intensive care admission
Time frame: At enrollment
Assess the patient's severity (APACHE II and SAPS II prognostic scores) based on the number of available beds at the time of admission
1 secondary outcome
Mortality
Time frame: From enrollment to the ICU discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Background: PubMed 26714805Robert R, Coudroy R, Ragot S, Lesieur O, Runge I, Souday V, Desachy A, Gouello JP, Hira M, Hamrouni M, Reignier J. Influence of ICU-bed availability on ICU admission decisions. Ann Intensive Care. 2015 Dec;5(1):55. doi: 10.1186/s13613-015-0099-z. Epub 2015 Dec 30.
- Background: PubMed 24699251Fuchs L, Novack V, McLennan S, Celi LA, Baumfeld Y, Park S, Howell MD, Talmor DS. Trends in severity of illness on ICU admission and mortality among the elderly. PLoS One. 2014 Apr 3;9(4):e93234. doi: 10.1371/journal.pone.0093234. eCollection 2014.
- Background: PubMed 31107397Barbash IJ, Wallace DJ, Kahn JM. Effects of Changes in ICU Bed Supply on ICU Utilization. Med Care. 2019 Jul;57(7):544-550. doi: 10.1097/MLR.0000000000001137.
- Background: PubMed 24408679Gooch RA, Kahn JM. ICU bed supply, utilization, and health care spending: an example of demand elasticity. JAMA. 2014 Feb 12;311(6):567-8. doi: 10.1001/jama.2013.283800. No abstract available.
- Background: PubMed 21306645Edbrooke DL, Minelli C, Mills GH, Iapichino G, Pezzi A, Corbella D, Jacobs P, Lippert A, Wiis J, Pesenti A, Patroniti N, Pirracchio R, Payen D, Gurman G, Bakker J, Kesecioglu J, Hargreaves C, Cohen SL, Baras M, Artigas A, Sprung CL. Implications of ICU triage decisions on patient mortality: a cost-effectiveness analysis. Crit Care. 2011;15(1):R56. doi: 10.1186/cc10029. Epub 2011 Feb 9.
- Background: PubMed 32319442Riccioni L, Bertolini G, Giannini A, Vergano M, Gristina G, Livigni S, Mistraletti G, Petrini Gruppo di Lavoro Siaarti-Societa Italiana di Anestesia Analgesia Rianimazione E Terapia Intensiva F. [Clinical ethics recommendations for the allocation of intensive care treatments, in exceptional, resource-limited circumstances.]. Recenti Prog Med. 2020 Apr;111(4):207-211. doi: 10.1701/3347.33183. Italian.
- Background: PubMed 27352032Churpek MM, Wendlandt B, Zadravecz FJ, Adhikari R, Winslow C, Edelson DP. Association between intensive care unit transfer delay and hospital mortality: A multicenter investigation. J Hosp Med. 2016 Nov;11(11):757-762. doi: 10.1002/jhm.2630. Epub 2016 Jun 28.
- Background: PubMed 21244671Cardoso LT, Grion CM, Matsuo T, Anami EH, Kauss IA, Seko L, Bonametti AM. Impact of delayed admission to intensive care units on mortality of critically ill patients: a cohort study. Crit Care. 2011;15(1):R28. doi: 10.1186/cc9975. Epub 2011 Jan 18.
- Background: PubMed 17440421Chalfin DB, Trzeciak S, Likourezos A, Baumann BM, Dellinger RP; DELAY-ED study group. Impact of delayed transfer of critically ill patients from the emergency department to the intensive care unit. Crit Care Med. 2007 Jun;35(6):1477-83. doi: 10.1097/01.CCM.0000266585.74905.5A.
- Background: PubMed 29384780Mathews KS, Durst MS, Vargas-Torres C, Olson AD, Mazumdar M, Richardson LD. Effect of Emergency Department and ICU Occupancy on Admission Decisions and Outcomes for Critically Ill Patients. Crit Care Med. 2018 May;46(5):720-727. doi: 10.1097/CCM.0000000000002993.
- Background: PubMed 33267777Czajka S, Ziebinska K, Marczenko K, Posmyk B, Szczepanska AJ, Krzych LJ. Validation of APACHE II, APACHE III and SAPS II scores in in-hospital and one year mortality prediction in a mixed intensive care unit in Poland: a cohort study. BMC Anesthesiol. 2020 Dec 2;20(1):296. doi: 10.1186/s12871-020-01203-7.
- Background: PubMed 8254858Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957.
- Individual participant dataSharing planned: No. There is no plan to share Individual Participant Data (IPD); however, anonymized data may be made available upon reasonable request, subject to sponsor approval and ethical considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Fiume study chair
UniCamillus - Saint Camillus International University of Health and Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care (ICU) and Intensive Care Unit (ICU) Admission, run by Saint Camillus International University of Health Sciences at 1 site in Italy.
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: opening soon, as of the sponsor's last update on 17 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 Italy. 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 Diego Fiume (0039 0651002979, diego.fiume@unicamillus.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of supply-induced demand for intensive care admission (time frame: At enrollment). 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 NCT07768410, which also lists 16 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 17 Aug 2026.