CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/05/087693 [Registered on: 27/05/2025] Trial Registered Prospectively

Last Modified On:

26/05/2025

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Single Arm Study

Public Title of Study

An observational study to assess nutrition practices in critically ill patients in India

Scientific Title of Study

The criticAl Care nUtrition mulTinational rEgistry

Trial Acronym

ACUTE

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	RENUKA M K
Designation	Professor and HOD
Affiliation	Sri Ramachandra Institute of Higher Education and Research
Address	Department of Critical Care Medicine SRIHER Chennai Chennai TAMIL NADU 600116 India
Phone	8056126336
Fax
Email	renuka.mk@sriramachandra.edu.in

Details of Contact Person
Scientific Query

Name	RENUKA M K
Designation	Professor and HOD
Affiliation	Sri Ramachandra Institute of Higher Education and Research
Address	Department of Critical Care Medicine SRIHER Chennai TAMIL NADU 600116 India
Phone	8056126336
Fax
Email	renuka.mk@sriramachandra.edu.in

Details of Contact Person
Public Query

Name	RENUKA M K
Designation	Professor and HOD
Affiliation	Sri Ramachandra Institute of Higher Education and Research
Address	Department of Critical Care Medicine SRIHER Chennai TAMIL NADU 600116 India
Phone	8056126336
Fax
Email	renuka.mk@sriramachandra.edu.in

Source of Monetary or Material Support

Sri Ramachandra Institute for Higher Education and Research. Porur, Chennai 600116 India

Primary Sponsor

Name	Sri Ramachandra Institute for Higher Education and Research
Address	Department of Critical Care Medicine Porur Chennai 600116 India
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

United States of America
Australia
Canada
Germany
India
Japan
Malaysia
New Zealand
Singapore
United Kingdom
China

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR RENUKA MK	Sri Ramachandra Institute of higher education and research	Department of Critical Care Medicine Porur chennai Thiruvallur TAMIL NADU	8056126336 renuka.mk@sriramachandra.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
instituitional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E46\|\|Unspecified protein-calorie malnutrition,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	Expected to be in need of ICU support for an additional 48 hours from screening.This is defined as ongoing organ function support on ICU (eg mechanical ventilation renal replacement therapy, or ongoing inotropic vasopressor support) Receiving any type of nutrition support

ExclusionCriteria

Details

Expected death or withdrawal of life-sustaining treatments within 7 days from screening

Readmitted to the ICU during the study period

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Oral oral nutrition supplements (ONS) enteral parenteral nutrition support At each day highest and lowest blood glucose highest lactate hypoglycemic events lowest phosphate Use of motility agents	4 weeks

Secondary Outcome

Outcome	TimePoints
Delta Sequential Organ Failure Assessment (SOFA) score Persistence of Organ Dysfunction (POD) defined as ongoing requirement for vasopressors dialysis or mechanical ventilation at the outcome assessments time points at each ICU day	4 weeks

Target Sample Size

Total Sample Size="200"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

16/06/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

26/06/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Malnutrition is common among critically ill patients and medical nutrition therapy in the form of enteral or parenteral nutrition is therefore considered an integral part of the standard care. While it is accepted that it is unethical to withhold nutrition therapy from those at risk of malnutrition evidence has been generated to demonstrate that various nutrition practices influence clinically important outcomes such as length of stay morbidity and mortality. Older data suggest that providing at least 80 percentage of prescribed amounts of protein and energy is associated with improved clinical outcomes Despite these benefits enteral or parenteral feeding practices themselves are not without adverse effects or risks. Making decisions regarding the most effective and safe means of feeding patients in the ICU can be challenging and consequently considerable variation exists in nutrition practices in this setting. By initiating the Critical Care Nutrition Multinational Registry we aim to describe current nutrition practices in different types of critically ill patients and to monitor changes over time in and between different countries worldwide.