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

Primary Purpose

Critical Illness, ARDS, Septic Shock

Status

Completed

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Replenish Protein

Standard protein

About this trial

This is an interventional other trial for Critical Illness focused on measuring Enteral nutrition, Intensive Care Units, caloric restriction, insulin, mortality, protein catabolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

Age ≥ 18 years
Mechanically ventilated
Receiving enteral feeding via nasogastric/orogastric or duodenal or PEG or jejunostomy tubes and
Expected to stay ≥ 1 week in the ICU

Exclusion criteria

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).
Patients not fed within 48 hours of admission
Patients on total parenteral nutrition (TPN)
Patients being fed orally
Chronic renal failure
Chronic liver disease
Renal replacement therapy
Pregnancy.
Kidney transplant
Post-liver transplant.
Post cardiac arrest.
Burn patients.
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;

New onset renal replacement therapy.
Acute Kidney Injury (serum creatinine > 3 times the preacute level or serum creatinine >350mmol/L with a recent increase of >44 mmols/L)
Significant liver impairment

Sites / Locations

King Abdulaziz Medical city
King Abdulaziz Medical city

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Replenish Protein group

Standard Protein group

Arm Description

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.

Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14

Outcomes

Primary Outcome Measures

Recruitment

Recruitment log

Retention rate

withdrawals

Achieved protein intake

Feeding data

Secondary Outcome Measures

Full Information

NCT ID

NCT03480555

First Posted

February 22, 2018

Last Updated

December 30, 2020

Sponsor

King Abdullah International Medical Research Center

1. Study Identification

Unique Protocol Identification Number

NCT03480555

Brief Title

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

Acronym

Replenish

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

May 16, 2018 (Actual)

Primary Completion Date

May 10, 2019 (Actual)

Study Completion Date

September 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King Abdullah International Medical Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness, ARDS, Septic Shock, Multiple Trauma, Seizure Disorder, Hemorrhagic Shock

Keywords

Enteral nutrition, Intensive Care Units, caloric restriction, insulin, mortality, protein catabolism

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Replenish Protein group

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Standard Protein group

Arm Type

Other

Arm Description

Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14

Intervention Type

Dietary Supplement

Intervention Name(s)

Replenish Protein

Other Intervention Name(s)

Intervention group

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Standard protein

Other Intervention Name(s)

Control group

Intervention Description

Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14

Primary Outcome Measure Information:

Title

Recruitment

Description

Recruitment log

Time Frame

6 months

Title

Retention rate

Description

withdrawals

Time Frame

14 days

Title

Achieved protein intake

Description

Feeding data

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Age ≥ 18 years Mechanically ventilated Receiving enteral feeding via nasogastric/orogastric or duodenal or PEG or jejunostomy tubes and Expected to stay ≥ 1 week in the ICU Exclusion criteria 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). Patients not fed within 48 hours of admission Patients on total parenteral nutrition (TPN) Patients being fed orally Chronic renal failure Chronic liver disease Renal replacement therapy Pregnancy. Kidney transplant Post-liver transplant. Post cardiac arrest. Burn patients. 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; New onset renal replacement therapy. Acute Kidney Injury (serum creatinine > 3 times the preacute level or serum creatinine >350mmol/L with a recent increase of >44 mmols/L) Significant liver impairment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yaseen M Arabi, MD

Organizational Affiliation

King Abdulaziz Medical City-Ministry of National Guard

Official's Role

Principal Investigator

Facility Information:

Facility Name

King Abdulaziz Medical city

City

Jeddah

ZIP/Postal Code

21423

Country

Saudi Arabia

Facility Name

King Abdulaziz Medical city

City

Riyadh

ZIP/Postal Code

11426

Country

Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will be shared with the other participating sites after the completion of the main study and upon the descretion of the study Principle investigator only

Citations:

PubMed Identifier

26773077

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. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). JPEN J Parenter Enteral Nutr. 2016 Feb;40(2):159-211. doi: 10.1177/0148607115621863. No abstract available. Erratum In: JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1200.

Results Reference

result

PubMed Identifier

26376142

Citation

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. No abstract available.

Results Reference

result

PubMed Identifier

28374096

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 Med. 2017 Sep;43(9):1239-1256. doi: 10.1007/s00134-017-4711-6. Epub 2017 Apr 3.

Results Reference

result

PubMed Identifier

34330462

Citation

Arabi YM, Al-Dorzi HM, Tamim H, Sadat M, Al-Hameed F, AlGhamdi A, Al Mekhlafi GA, Rasool G, Afesh L, Sakkijha MH, Alamrey NK, Malebari R, Alhutail RH, Al-Dawood A; Saudi Critical Care Trials Group. Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: A pilot randomized controlled trial (REPLENISH pilot trial). Clin Nutr ESPEN. 2021 Aug;44:166-172. doi: 10.1016/j.clnesp.2021.05.008. Epub 2021 Jun 2.

Results Reference

derived

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

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