ClinicalTrials.gg
CompletedNCT03318965Updated Oct 24, 2017

Scoring Systems in ICU and Malnutrition

An observational study in Critical Illness, sponsored by Shahid Beheshti University. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2017-10-24.

Sponsored by Shahid Beheshti University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
304
Ages
16 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Critical Illness

Browse trials for

Keywords

  • Mortality
  • Anthropometry
  • Nutrition Assessment
  • Caliper
03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's enrollment of 304 is above the median of 140 across 814 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Shahid Beheshti University is the lead sponsor of 37 studies on the registry; 3 are open to participants now.

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

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

304 eligible critically ill patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Older than 16 years of age

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
304 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Prediction of Mortality

    Mortality prediction by APACHE -APM

    Time frame: First day of ICU admission

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2014 to primary completion in Nov 2016, 29 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2017
First posted
Oct 24, 2017
StartActual
Jun 2014
Primary completionActual
Nov 2016
CompletionActual
Nov 2016
Last update
Oct 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03318965
Lead sponsor
Shahid Beheshti University
Responsible party
Zahra Vahdat Shariatpanahi (Associate Professor, Shahid Beheshti University) — Principal investigator
First posted
Oct 24, 2017
Start date
Jun 2014
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Oct 24, 2017

Study contacts

Zahra Vahdat Shariatpanahi, MD, PhD
study chair · Shahid Beheshti University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion