NCT06665529

Brief Summary

There are several scores for predicting mortality within 28 days in the intensive care unit, including APACHE 2, MPM 2 and MODS. These models for predicting mortality can help intensive care physicians to identify patients at high risk of mortality, thus helping them in the decision regarding their admission to the ICU and the management of their care during hospitalization. However, it is not entirely clear whether these models can predict mortality better than an experienced ICU physician or nurse. The purpose of the study is to compare the ability of a senior ICU physician and nurse to predict mortality within 28 days in intensive care patients and between the predictive ability of three models for mortality prediction, as well as to investigate what were the parameters that particularly influenced the mortality prediction of the medical and nursing staff. The study will be performed as a prospective observational study and will include approximately 2000 patients. For each patient admitted to intensive care, the risk of mortality will be calculated according to APACHE 2, MPM 2 and MODS. In addition, an independent evaluation by 3 specialist ICU physicians and an experienced ICU nurse will be carried out. The medical and nursing staff's reasons for the risk provided by them will be presented.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Feb 2025

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

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Study Timeline

Key milestones and dates

Study Progress66%
Feb 2025Jan 2027

First Submitted

Initial submission to the registry

October 28, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 13, 2025

Status Verified

May 1, 2025

Enrollment Period

1.9 years

First QC Date

October 28, 2024

Last Update Submit

May 7, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality prediction by ICU staff vs. mortality scores

    28-day mortality prediction by ICU staff (three senior physicians and ICU nurse) and mortality scores (APACHE 2, MPM 2 and MODS).

    2 years

Interventions

28-day mortality prediction by ICU staff (three senior physicians and ICU nurse) and mortality scores (APACHE 2, MPM 2 and MODS).

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the ICU between 1.1.2025 and 1.1.2027.

You may qualify if:

  • All patients admitted to the ICU between 1.1.2025 and 1.1.2027.

You may not qualify if:

  • Patients who were hospitalized in the ICU for less than 72 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 28, 2024

First Posted

October 30, 2024

Study Start

February 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

May 13, 2025

Record last verified: 2025-05

Locations