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CompletedNCT02663505Updated Jan 25, 2018

Development of an ICU Risk Score

An observational study in Development of a Risk Score for ICU Admission, sponsored by University Hospital Schleswig-Holstein. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-25.

Sponsored by University Hospital Schleswig-Holstein · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
6,918
Ages
18 Years and older
Sex
All
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Study summary

Intensive care units are inevitable for high risk surgery and/or high risk patients i.e. patients with severe preconditions. However, usually the capacity of these units is limited such that at times elective surgery has to be postponed if there is no ICU capacity.

The aim of this study is to investigate potential influence/risk factors important for ICU admission in a university hospital in Germany and develop a risk score. In a second phase the risk score for ICU admission will be validated.

Read the detailed description

It is one of the core duties of anesthesiologists in our hospital to identify patients with high risk for a post-surgery ICU stay upon hospital admission. We do know that there are two types of factors influencing the possibility of an ICU admission: The patient centered risk e.g. severe preconditions and the surgery centered risk depending on the type of surgery with sometimes high possibility for perioperative complications i.e. bleeding, hemodynamic instability, pulmonary complications etc. However, we do not know the effect size of these factors and, equally important, how they are correlated with one another.

The aim of this study is to model the risk of an ICU stay by patient centered and surgery centered influence factors. If a good model is obtained, this can be utilized for allocating ICU capacities in an objective fashion. The study consists of two phases. In the first phase model selection is performed. In the second phase the developed model will be validated on independent data. Data will be gathered by a data collection sheet completed by the responsible anesthesiologists in all elective and emergency surgery during a specific period of time.

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Conditions studied

  • Development of a Risk Score for ICU Admission
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In context

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

All patients meeting inclusion criteria and receiving elective or emergency surgery

Inclusion criteria

  • All patients ≥ 18 years receiving surgery in the time frame of data collection with ASA classification status I-IV

Exclusion criteria

Exclusion Criteria:

  • Patients \< 18 years
  • ASA classification status > IV
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
6,918 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

    Patients receiving either elective or emergency surgery.

    Procedure: Patients receiving the surgery planned for them

Interventions

  • ProcedurePatients receiving the surgery planned for them

    For each patient the following potential influence (risk) factors are documented: sex, urgency of the operation, BMI, age, ASA classification, preconditions, physical fitness, Hb value. In phase 2 only selected influence factors will be recorded. No intervention will be performed apart from the surgery planned for each patient.

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What researchers measure

Primary outcomes

  1. The necessity of an ICU stay

    This is recorded by the responsible anesthesiologist after the completion of surgery.

    Time frame: Immediately after surgery

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Study locations

1 site
  • University Hospital Schleswig-Holstein, Campus Kiel
    Kiel, 24105, Germany
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References and documents

Publications

  • Orsini J, Blaak C, Yeh A, Fonseca X, Helm T, Butala A, Morante J. Triage of Patients Consulted for ICU Admission During Times of ICU-Bed Shortage. J Clin Med Res. 2014 Dec;6(6):463-8. doi: 10.14740/jocmr1939w. Epub 2014 Sep 9. PubMed 25247021 ↗
  • Lupei MI, Chipman JG, Beilman GJ, Oancea SC, Konia MR. The association between ASA status and other risk stratification models on postoperative intensive care unit outcomes. Anesth Analg. 2014 May;118(5):989-94. doi: 10.1213/ANE.0000000000000187. PubMed 24781569 ↗
  • Wanderer JP, Anderson-Dam J, Levine W, Bittner EA. Development and validation of an intraoperative predictive model for unplanned postoperative intensive care. Anesthesiology. 2013 Sep;119(3):516-24. doi: 10.1097/ALN.0b013e31829ce8fd. PubMed 23756454 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02663505
Lead sponsor
University Hospital Schleswig-Holstein
Responsible party
Timo Iden (MD, University Hospital Schleswig-Holstein) — Principal investigator
First posted
Jan 26, 2016
Start date
Feb 2016
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Jan 25, 2018

Study contacts

Matthias Grünewald, MD
study chair · University Hospital Schleswig-Holstein, Campus Kiel, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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