Critical IllnessReplenishNCT03480555
Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients
A study testing Replenish Protein and Standard protein in people with Critical Illness and ARDS, run by King Abdullah International Medical Research Center at 2 sites in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, ARDS, Septic Shock
- What is being tested?
- Replenish Protein and Standard protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 16 May 2018to 10 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
King Abdulaziz Medical city
Jeddah, 21423
King Abdulaziz Medical city
Riyadh, 11426
About this study
Official title: Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: Feasibility Randomized Controlled Trial
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.
Read the 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
- Conditions
- Critical Illness, ARDS, Septic Shock, Multiple Trauma, Seizure Disorder, Hemorrhagic Shock
- Being tested
- Replenish Protein, Standard protein
- Keywords
- Enteral nutrition, Intensive Care Units, caloric restriction, insulin, mortality, protein catabolism
- Medical subject headings
- Critical Illness, Shock, Septic, Multiple Trauma, Epilepsy, Shock, Hemorrhagic, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replenish ProteinDietary supplement
Also called Intervention group
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 proteinDietary supplement
Also called Control group
Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14
| Study group | Role | What they receive |
|---|---|---|
| Replenish Protein group | Active comparator | 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. Receives: Dietary Supplement: Replenish Protein |
| Standard Protein group | Other | Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14 Receives: Dietary Supplement: Standard protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment log
Measured: 6 months
Retention rate
withdrawals
Measured: 14 days
Achieved protein intake
Feeding data
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start16 May 2018
- Primary completion10 May 2019
- Study completion10 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaseen M Arabi, MD, Principal investigator, King Abdulaziz Medical City-Ministry of National Guard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480555
- Sponsor's protocol ID
- RC17/252/R
- Acronym
- Replenish
- Status last verified
- Dec 2020
- First submitted
- 22 Feb 2018
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 26773077Arabi 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.
PubMed 26376142Arabi 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.
PubMed 28374096Arabi 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.
PubMed 34330462
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03480555
- Acronym / sponsor ID
- Replenish / RC17/252/R
- Conditions
- Critical Illness, ARDS, Septic Shock, Multiple Trauma, Seizure Disorder, Hemorrhagic Shock
- Keywords
- Enteral nutrition, Intensive Care Units, caloric restriction, insulin, mortality, protein catabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 Sep 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Replenish Protein group | Active comparator | Dietary Supplement: Replenish ProteinSubjects 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 group | Other | Dietary Supplement: Standard proteinSubjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- Lack of commitment to ongoing life support, which includes;
- Patients not fed within 48 hours of admission
- Patients on total parenteral nutrition (TPN)
- Patients being fed orally
- Chronic renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Replenish ProteinAlso: Intervention groupSubjects 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. | Dietary supplement | Replenish Protein group |
| Standard proteinAlso: Control groupSubjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14 | Dietary supplement | Standard Protein group |
Primary outcome
Recruitment
Time frame: 6 months
Recruitment log
Retention rate
Time frame: 14 days
withdrawals
Achieved protein intake
Time frame: 14 days
Feeding data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Results publication: PubMed 26773077McClave 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.
- Results publication: PubMed 26376142Arabi 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 publication: PubMed 28374096Arabi 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.
- Derived from this study: PubMed 34330462Arabi 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaseen M Arabi, MD principal investigator
King Abdulaziz Medical City-Ministry of National Guard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Replenish Protein and Standard protein in people with Critical Illness and ARDS, run by King Abdullah International Medical Research Center at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03480555, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.