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

The Association of Protein-Energy Adequacy With Mortality in Critically Ill Patients With Acute Kidney Injury. A Prospective Observational Single- Centre Study.

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Acute Kidney Injury

Detailed Description

Patients with Acute Kidney Injury, AKI are probably more exposed to the risk of malnutrition especially if they undergo Renal Replacement Therapy, RRT. Optimization of nutrients especially energy and protein can ensure a better health outcome for critically ill patients with AKI. Moreover, there is no research on the association of Protein- Energy adequacy with mortality among critically ill patients with AKI in Malaysia. So, the main purpose of this study is to investigate the relationship of Protein-Energy adequacy with mortality among critically ill patients with AKI

Subjects will be recruited upon admission in ICU after fulfilling the inclusion and exclusion criteria. They will be follow up from day 1 until day 14 or until ICU Discharge. Data including Demographic, Clinical, Laboratory, and Nutritional Status will be recorded. On Day 28, the outcome data including Mortality, length of ICU Stay, and Length of Ventilator day will be recorded.

• Study Type: Observational
• Enrollment (Anticipated): 185

Contacts and Locations

• Study Contact: Name: MOHD SHAHNAZ HASAN, MBBS; Phone Number: 3869 0379493869; Email: shahnaz@ummc.edu.my
• Study Contact Backup: Name: MOHAMAD IRFAN OTHMAN JAILANI, DIETETICS; Phone Number: 3869 0379493869; Email: mioj92@gmail.com

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • Recruiting
    • University Malaya Medical Centre
    • Contact: MOHD SHAHNAZ HASAN, MBBS; Phone Number: 3869 0379493869; Email: shahnaz@ummc.edu.my

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who are less than 18 years old
2. End-stage renal disease patients
3. Patients undergo kidney transplantation within 3 months before ICU admission
4. Pregnant patients
5. 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)
6. Prior treatment with RRT within 30 days
7. Anticipated alive ICU discharge within 24 hours
8. Readmission to the ICU during the same hospitalization episode.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
28-Days Mortality	Mortality status of subjects on day 28 from recruitment.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU Stay	Duration of ICU Stay from ICU admission until ICU discharge	1 day
Length of Ventilator Day	Duration of ventilator used by subjects from ICU admission until ICU discharge	1 day

Collaborators and Investigators

• Sponsor: University of Malaya
• Investigators: Principal Investigator: MOHD SHAHNAZ HASAN, MBBS, University of Malaya

Publications and helpful links

Helpful Links

• ESPEN Guideline on Clinical Nutrition in the Intensive Care Unit. Clinical Nutrition
• Nutritional management of acute kidney injury in the critically ill: a focus on enteral feeding.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: August 27, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): September 3, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Energy; Mortality; Adequacy; Protein
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Wounds and Injuries; Critical Illness; Acute Kidney Injury
• Other Study ID Numbers: MREC ID NO: 2018222-6043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No