The Association of Protein-Energy Adequacy With Mortality in Critically Ill Patients With Acute Kidney Injury.

NCT04533100 | Unknown

• 1 other identifier: MREC ID NO: 2018222-6043
• Study Type: observational
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational single-center study in which the association of Protein-Energy Adequacy and 28-Days of Mortality among critically ill patients with Acute Kidney Injury, AKI will be investigated. The association of Protein-Energy adequacy with a length of ICU and hospital stay, total ventilator, and inotropic drug days among critically ill patients with AKI also will be investigated.

Conditions

Critical Illness; Acute Kidney Injury

Keywords

Protein; Energy; Adequacy; Mortality

Outcome Measures

Primary Outcomes (1)

• 28-Days Mortality

  Mortality status of subjects on day 28 from recruitment.

  1 day

Secondary Outcomes (2)

• Length of ICU Stay

  1 day

• Length of Ventilator Day

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will be conducted in adult Intensive Care Unit, University Malaya Medical Centre (UMMC), Malaysia.

You may qualify if:

• Patients who are 18 years old and older
• Patients who are admitted to the participating ICU.
• Patients who are mechanically ventilated.

You may not qualify if:

• Patients who are less than 18 years old
• End-stage renal disease patients
• Patients undergo kidney transplantation within 3 months before ICU admission
• Pregnant patients
• The patient is moribund with expected death within 24 hour or whom survival to 28 days is unlikely due to uncontrollable comorbidity (cardiac, pulmonary or hepatic end-stage disease; hepatorenal syndrome; poorly controlled cancer; severe post-anoxic encephalopathy and others)
• Prior treatment with RRT within 30 days
• Anticipated alive ICU discharge within 24 hours
• Readmission to the ICU during the same hospitalization episode.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

RECRUITING

Related Links

• ESPEN Guideline on Clinical Nutrition in the Intensive Care Unit. Clinical Nutrition

MeSH Terms

Conditions

Critical Illness; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• MOHD SHAHNAZ HASAN, MBBS

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MOHD SHAHNAZ HASAN, MBBS

CONTACT

0379493869; shahnaz@ummc.edu.my

MOHAMAD IRFAN OTHMAN JAILANI, DIETETICS

CONTACT

0379493869; mioj92@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator.

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: August 31, 2020
• Study Start: July 20, 2020
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

MY (1)