Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients

Critical Illness Clinical Trial

— Replenish  

Official title:

Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: Feasibility Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480555
• Other study ID #: RC17/252/R
• Status: Completed
• Phase: N/A
• Start date: May 16, 2018
• Est. completion date: September 10, 2019

Study information

• Verified date: December 2020
• Source: King Abdullah International Medical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we will explore the feasibility of a randomized controlled trial that will compare high protein dose from ICU day 6 to 14 with moderate protein intake.

Description:

Patients will be recruited on day 1-2 of ICU admission. On day 5, patients will be randomized into one of the two intervention arms; Replenish Protein group: Patients randomized to this group will receive 2 g of protein/kg/day (acceptable range 1.8 - 2.2 g of protein/kg/day) for day 6-14. Standard Protein group: Patients randomized to this group will receive protein at 0.8 - 1.0 g of protein/kg/day for day 6-14

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Age = 18 years

2. Mechanically ventilated

3. Receiving enteral feeding via nasogastric/orogastric or duodenal or PEG or jejunostomy tubes and

4. Expected to stay = 1 week in the ICU Exclusion criteria

1. Lack of commitment to ongoing life support, which includes;

• Terminal Illness (Malignancy or irreversible condition with 6 month mortality > 50%)
• DNR order in the first 48 hours and brain death within 48 hours of admission) (Don't include the presence of a "Do Not Resuscitate" order alone, if there is a commitment to ongoing life support).

2. Patients not fed within 48 hours of admission

3. Patients on total parenteral nutrition (TPN)

4. Patients being fed orally

5. Chronic renal failure

6. Chronic liver disease

7. Renal replacement therapy

8. Pregnancy.

9. Kidney transplant

10. Post-liver transplant.

11. Post cardiac arrest.

12. Burn patients.

13. Prisoners Screened patients will be screened again for eligibility at day 5, should be mechanically ventilated and expected to stay = 3 days in the ICU. At this point, patients will be excluded if they meet the following;

1. New onset renal replacement therapy.

2. Acute Kidney Injury (serum creatinine > 3 times the preacute level or serum creatinine >350mmol/L with a recent increase of >44 mmols/L)

3. Significant liver impairment

Related Conditions & MeSH terms

• ARDS
• Critical Illness
• Epilepsy
• Hemorrhagic Shock
• Multiple Trauma
• Seizure Disorder
• Seizures
• Septic Shock
• Shock
• Shock, Hemorrhagic

Intervention

Dietary Supplement:
• Replenish Protein
Subjects randomized to this group will receive 2 g of protein/kg/day (acceptable range as 1.8 - 2.2 g of protein/kg/day) for day 6-14.
• Standard protein
Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14

Locations

Country	Name	City	State
Saudi Arabia	King Abdulaziz Medical city	Jeddah
Saudi Arabia	King Abdulaziz Medical city	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah International Medical Research Center

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (3)

Arabi YM, Aldawood AS, Solaiman O. Permissive Underfeeding or Standard Enteral Feeding in Critical Illness. N Engl J Med. 2015 Sep 17;373(12):1175-6. doi: 10.1056/NEJMc1509259. — View Citation

Arabi YM, Casaer MP, Chapman M, Heyland DK, Ichai C, Marik PE, Martindale RG, McClave SA, Preiser JC, Reignier J, Rice TW, Van den Berghe G, van Zanten ARH, Weijs PJM. The intensive care medicine research agenda in nutrition and metabolism. Intensive Care — View Citation

McClave SA, Taylor BE, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society for Parenteral and Enteral Nutrition — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment	Recruitment log	6 months
Primary	Retention rate	withdrawals	14 days
Primary	Achieved protein intake	Feeding data	14 days