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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

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Keywords

  • Mortality
  • Anthropometry
  • Nutrition Assessment
  • Caliper
03

Who can participate

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

Study population

304 eligible critically ill patients

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
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
304 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Prediction of Mortality

    Mortality prediction by APACHE -APM

    Time frame: First day of ICU admission

06

Study locations

No study locations are listed for this record.

07

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 ↗

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