Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit

• Sponsor: Qilu Hospital of Shandong University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04670458
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 133.5

Study Details

Study Description

Brief Summary

Current studies have shown that hospitalized ICU patients have a high risk of IHCA, with an incidence of about 0.6-7.8%. Early prediction of the occurrence of IHCA in severe patients can provide early intervention, prevent the deterioration of the disease, and reduce the incidence of IHCA. Therefore, researchers wanted to verify the efficacy of MEWS, NEWS, and CART scores in predicting IHCA in ICU inpatients, and to establish an early-warning scoring model that could effectively predict the risk of IHCA occurrence in ICU inpatients during hospitalization.

Condition or Disease	Intervention/Treatment	Phase
In-Hospital Cardiac Arrest	Other: no intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 2000 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Derivation of An In-Hospital Cardiac Arrest Prediction Model for Patients in Intensive Care Unit
• Actual Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
CA group Patients with In-Hospital Cardiac Arrest	Other: no intervention; no intervention
CONTROL group Patients without In-Hospital Cardiac Arrest	Other: no intervention; no intervention

Outcome Measures

Primary Outcome Measures

1. In-Hospital Cardiac Arrest [Day 2]

   Cardiac arrest occurs during hospitalization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

CA group

Inclusion Criteria:

• Occurrence of IHCA

• Hospital stay ≥48h.

Exclusion Criteria:

• <14 years

• Do Not Resuscitat

• Patients hospitalized due to out-of-hospital cardiac arrest

• Cardiac arrest occurs during the operation

• The patients with implanted cardiac pacemaker suffered cardiac arrest due to instrument malfunction.

CONTROL group

Inclusion Criteria:

• Without IHCA

• Hospital stay ≥48h

Exclusion Criteria:

• <14 years

• Leave hospital without medical advice

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Qilu Hospital of Shandong University	Jinan	Shandong	China	250012

Sponsors and Collaborators

• Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Qilu Hospital of Shandong University
• ClinicalTrials.gov Identifier: NCT04670458
• Other Study ID Numbers: IHCA-EWS-QLH
• First Posted: Dec 17, 2020
• Last Update Posted: Dec 17, 2020
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Qilu Hospital of Shandong University: Critically ill patients; In-Hospital Cardiac Arrest; Early recognition; Early warning score
• Additional relevant MeSH terms: Heart Arrest

Study Results

No Results Posted as of Dec 17, 2020