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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04533100
• Other study ID #: MREC ID NO: 2018222-6043
• Status: Recruiting
• Start date: July 20, 2020
• Est. completion date: August 2021

Study information

• Verified date: September 2020
• Source: University of Malaya
• Contact: MOHD SHAHNAZ HASAN, MBBS
• Phone: 0379493869
• Email: shahnaz[@]ummc.edu.my
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 185
• Est. completion date: August 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Wounds and Injuries

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-Days Mortality	Mortality status of subjects on day 28 from recruitment.	1 day
Secondary	Length of ICU Stay	Duration of ICU Stay from ICU admission until ICU discharge	1 day
Secondary	Length of Ventilator Day	Duration of ventilator used by subjects from ICU admission until ICU discharge	1 day

External Links

•   Calorie intake and patient outcomes in severe acute kidney injury: findings from The Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study trial.
•   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.