Development of a Risk Score for ICU AdmissionNCT02663505
Development of an ICU Risk Score
An observational study of Development of a Risk Score for ICU Admission, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Development of a Risk Score for ICU Admission
- What is being tested?
- Patients receiving the surgery planned for them
- Type of treatment
- Surgery or procedure
- How many people
- 6,918 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients meeting inclusion criteria and receiving elective or emergency surgery
Who may be able to join
- All patients ≥ 18 years receiving surgery in the time frame of data collection with ASA classification status I-IV
Who cannot join
- Patients < 18 years
- ASA classification status > IV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: I See You Risk Your ICU Capacity - Development Of An ICU Risk Score
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.
- Being tested
- Patients receiving the surgery planned for them
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients receiving the surgery planned for themProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients receiving either elective or emergency surgery. Receives: Procedure: Patients receiving the surgery planned for them |
What is being measured
The primary outcome is the main question the study is designed to answer.
The necessity of an ICU stay
This is recorded by the responsible anesthesiologist after the completion of surgery.
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Development of a Risk Score for ICU AdmissionStudies 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
- Prospective
- Enrolment
- 6,918 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timo Iden, University Hospital Schleswig-Holstein
- Investigators
- Matthias Grünewald, MD, Study chair, University Hospital Schleswig-Holstein, Campus Kiel, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663505
- Sponsor's protocol ID
- ICU Risk Score
- Status last verified
- Jan 2018
- First submitted
- 12 Jan 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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 25247021Lupei 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 24781569Wanderer 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I See You Risk Your ICU Capacity - Development Of An ICU Risk Score
- ClinicalTrials.gov ID
- NCT02663505
- Acronym / sponsor ID
- ICU Risk Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,918 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 26 Jan 2016 (estimated)
- 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Patients receiving the surgery planned for themPatients receiving either elective or emergency surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients meeting inclusion criteria and receiving elective or emergency surgery
Key inclusion criteria (1 listed)
- All patients ≥ 18 years receiving surgery in the time frame of data collection with ASA classification status I-IV
Key exclusion criteria (2 listed)
- Patients < 18 years
- ASA classification status > IV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients receiving the surgery planned for themFor 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. | Procedure or surgery | Group 1 |
Primary outcome
The necessity of an ICU stay
Time frame: Immediately after surgery
This is recorded by the responsible anesthesiologist after the completion of surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Background: PubMed 25247021Orsini 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.
- Background: PubMed 24781569Lupei 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.
- Background: PubMed 23756454Wanderer 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.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Matthias Grünewald, MD study chair
University Hospital Schleswig-Holstein, Campus Kiel, Germany
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 Development of a Risk Score for ICU Admission, run by University Hospital Schleswig-Holstein at 1 site in Germany.
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 2 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: finished, as of the sponsor's last update on 25 Jan 2018. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The necessity of an ICU stay (time frame: Immediately after surgery). 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 NCT02663505, which also lists 3 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 25 Jan 2018.