Critical IllnessNCT03318965
Scoring Systems in ICU and Malnutrition
An observational study of Critical Illness, run by Shahid Beheshti University.
Trial summary
The objective of the present study was to compare the ability of acute physiology and chronic health evaluation (APACHE) scoring systems with the combination of an anthropometric variable score "adductor pollicis muscle (APM) thickness" to the APACHE systems in predicting mortality in the ICU. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 304 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Nov 2016
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: 304 eligible critically ill patients
Who may be able to join
- Older than 16 years of age
Who cannot join
- Splints, in the upper extremities
- Casts in the upper extremities
- Edema in the upper extremities
- Patients with readmission during the study period
- Those transferred from other ICUs
About this study
Official title: Combination of APACHE Scoring Systems With Adductor Pollicis Muscle Thickness for the Prediction of Mortality in ICU
The objective of the present study was to compare the ability of acute physiology and chronic health evaluation (APACHE) scoring systems with the combination of an anthropometric variable score "adductor pollicis muscle (APM) thickness" to the APACHE systems in predicting mortality in the ICU. Three hundred and four patients enrolled in this prospective observational study. The APM thickness in dominant hand and APACHE II and III scores were measured for each patient upon admission. Given scores for the APM thickness, were added to APACHE score systems to make two composite scores of APACHE II- APM and APACHE III- APM. The accuracy of the two composite models and APACHE II and III systems in predicting mortality of patients was compared using area under the ROC curve.
Based on the study results, the area under the ROC curves improved in composite models. Therefore, it seemed that considering anthropometric variables may improve prediction of mortality in APACHE systems.
Read the detailed description
The baseline medical history, physical examination, Acute Physiology and Chronic Health Evaluation score II and III (APACHE) were recorded for all patients. All data were collected by a single physician. The APACHE II and III scores were gathered using the method presented by Knaus. The dominant hand APM thickness (as reported by the patient, or the relative) was assessed by Caliper (Vogel, Germany) in the emergency room or at the time of the ICU admission. To estimate weight for the APM thickness, multivariate logistic regression analysis was used to determine the relation between mortality and the APM thickness while controlling for other physiologic variables (12 physiologic variables for APACHE II and 18 physiologic variables for APACHE III).The area under the receiver-operating curves (ROC curve) to predict mortality was used to compare APACHE II, APACHE III, APACHE II- APM and APACHE III- APM systems.
- Conditions
- Critical Illness
- Keywords
- Mortality, Anthropometry, Nutrition Assessment, Caliper
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of Mortality
Mortality prediction by APACHE -APM
Measured: First day of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study startJun 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Vahdat Shariatpanahi, Shahid Beheshti University
- Investigators
- Zahra Vahdat Shariatpanahi, MD, PhD, Study chair, Shahid Beheshti University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318965
- Sponsor's protocol ID
- 1374103
- Status last verified
- Oct 2017
- First submitted
- 10 Oct 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of APACHE Scoring Systems With Adductor Pollicis Muscle Thickness for the Prediction of Mortality in ICU
- ClinicalTrials.gov ID
- NCT03318965
- Acronym / sponsor ID
- 1374103
- Conditions
- Critical Illness
- Keywords
- Mortality, Anthropometry, Nutrition Assessment, Caliper
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 24 Oct 2017 (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.
The objective of the present study was to compare the ability of acute physiology and chronic health evaluation (APACHE) scoring systems with the combination of an anthropometric variable score "adductor pollicis muscle (APM) thickness" to the APACHE systems in predicting mortality in the ICU. Three hundred and four patients enrolled in this prospective observational study. The APM thickness in dominant hand and APACHE II and III scores were measured for each patient upon admission. Given scores for the APM thickness, were added to APACHE score systems to make two composite scores of APACHE II- APM and APACHE III- APM. The accuracy of the two composite models and APACHE II and III systems in predicting mortality of patients was compared using area under the ROC curve.
Based on the study results, the area under the ROC curves improved in composite models. Therefore, it seemed that considering anthropometric variables may improve prediction of mortality in APACHE systems.
Detailed description
The baseline medical history, physical examination, Acute Physiology and Chronic Health Evaluation score II and III (APACHE) were recorded for all patients. All data were collected by a single physician. The APACHE II and III scores were gathered using the method presented by Knaus. The dominant hand APM thickness (as reported by the patient, or the relative) was assessed by Caliper (Vogel, Germany) in the emergency room or at the time of the ICU admission. To estimate weight for the APM thickness, multivariate logistic regression analysis was used to determine the relation between mortality and the APM thickness while controlling for other physiologic variables (12 physiologic variables for APACHE II and 18 physiologic variables for APACHE III).The area under the receiver-operating curves (ROC curve) to predict mortality was used to compare APACHE II, APACHE III, APACHE II- APM and APACHE III- APM systems.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 304 eligible critically ill patients
Key inclusion criteria (1 listed)
- Older than 16 years of age
Key exclusion criteria (5 listed)
- Splints, in the upper extremities
- Casts in the upper extremities
- Edema in the upper extremities
- Patients with readmission during the study period
- Those transferred from other ICUs
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
Prediction of Mortality
Time frame: First day of ICU admission
Mortality prediction by APACHE -APM
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 24 Oct 2017.
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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. This study is not recruiting at the moment.
Zahra Vahdat Shariatpanahi, MD, PhD study chair
Shahid Beheshti University
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Shahid Beheshti University.
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 5 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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Prediction of Mortality (time frame: First day of ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2017.