Critical IllnessREPLENISHNCT04475666
Replacing Protein Via Enteral Nutrition in Critically Ill Patients
A study testing Replenish protein group and Standard protein group in people with Critical Illness and Nutrition Disorders, run by King Abdullah International Medical Research Center at 2 sites in Saudi Arabia.
Trial summary
The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Nutrition Disorders
- What is being tested?
- Replenish protein group and Standard protein group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,502 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 21 Sep 2020to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Lack of commitment to full life support or brain death. Patients with "Do Not Resuscitate" order but with commitment to ongoing life support can be enrolled.
- Patients on any amount of parenteral nutrition (PN) in ICU at the time of screening, whether PN is used alone or in combination with enteral nutrition. Non-nutritional calories (dextrose, propofol, citrate) not considered as PN.
- Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days.
- Patients being fed entirely through oral route - i.e. those who are eating.
- Pregnancy.
- Burn patients.
Show all 10Show fewer
- Prisoners or those undergoing forced treatment.
- Patients with hepatic encephalopathy or Child C liver cirrhosis
- Inherited defect of amino acid metabolism.
- Allergies to protein supplement
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia2 sites, 2 recruiting
- Recruiting
King Abdulaziz Medical city
Jeddah, Jeddah, 21423
Fahad M Al-Hameed, MD, 00966 12 2266666 ext. 22771, HameedF@ngha.med.sa
Ohoud Al Orabi, MMedSC, 0096612 2266666 ext. 28864, alorabioh@NGHA.MED.SA
- Recruiting
Intensive Care Unit, King Abdulaziz Medical City
Riyadh, 11426
About this study
Official title: Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: An International, Multicenter Randomized Controlled Trial
The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.
Read the detailed description
The REPLENISH is a multicentric, international, open label, randomized controlled trial which will enroll subjects in intensive care unit. Patients will be randomized on day 4 of ICU admission. Until ICU day 4, protein requirement will be provided according to the local practice as long as no intravenous amino acids are given and the average protein intake in the first 4 days does not exceed 0.8 g/kg/day. On ICU day 4, patients will be randomized to one of the two treatment groups: one with standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula and another group will receive the standard amount of proteins (maximum 1.2 g/kg/day) from the primary polymeric formula AND supplemental protein at 1.2 g/kg/day.
Randomization will be stratified by suspected COVID-19 and then by site and the use of renal replacement therapy at the time of randomization (intermittent hemodialysis or continuous renal replacement therapy.
- Conditions
- Critical Illness, Nutrition Disorders
- Being tested
- Replenish protein group, Standard protein group
- Medical subject headings
- Critical Illness, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Replenish protein groupOther
For patients with Body mass index(BMI) <30, use pre-ICU actual body weight(BW) for the calculation; if unavailable, use weight on ICU admission. For patients with BMI >=30, use adjusted body weight
Standard protein groupOther
For patients with BMI <30, use pre-ICU actual BW for the calculation; if unavailable, use weight on ICU admission. For patients with BMI >=30, use adjusted body weight
| Study group | Role | What they receive |
|---|---|---|
| Replenish protein group | Active comparator | The subjects randomized to this group will receive the standard amount of proteins (maximum 1.2 g/kg/day) from the primary polymeric formula AND supplemental protein at 1.2 g/kg/day Receives: Other: Replenish protein group |
| Standard protein group | Active comparator | The subjects randomized to this group will receive standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula. No supplemental protein will be allowed Receives: Other: Standard protein group |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 day-all cause mortality
Mortality 90 days post randomization
Measured: 90 days
Secondary outcomes (5)
Days alive at day 90 without life support
use of vasopressor/inotropic support, invasive mechanical ventilation and/or renal replacement therapy
Measured: 90 days
Days alive and out of hospital at day 90
90 day survival after randomization
Measured: 90 days
Bacteremia until 2 days of ICU stay
Any symptoms of bacteremia
Measured: until 2 days post ICU.
New or progression of Skin Pressure Ulcers
anytime during ICU stay
Measured: ICU stay
Functional assessment at day 90
SARC-F screen for sarcopenia and EuroQoL
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start21 Sep 2020
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,502 participants (estimated)
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 Saud Bin Abdulaziz University for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04475666
- Sponsor's protocol ID
- RC19/414/R
- Acronym
- REPLENISH
- Status last verified
- Aug 2025
- First submitted
- 7 Jun 2020
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liebau F, Wernerman J, van Loon LJ, Rooyackers O. Effect of initiating enteral protein feeding on whole-body protein turnover in critically ill patients. Am J Clin Nutr. 2015 Mar;101(3):549-57. doi: 10.3945/ajcn.114.091934. Epub 2015 Feb 4.
PubMed 25733640McClave 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 26773077Compher C, Chittams J, Sammarco T, Nicolo M, Heyland DK. Greater Protein and Energy Intake May Be Associated With Improved Mortality in Higher Risk Critically Ill Patients: A Multicenter, Multinational Observational Study. Crit Care Med. 2017 Feb;45(2):156-163. doi: 10.1097/CCM.0000000000002083.
PubMed 28098623Weijs PJ, Looijaard WG, Beishuizen A, Girbes AR, Oudemans-van Straaten HM. Early high protein intake is associated with low mortality and energy overfeeding with high mortality in non-septic mechanically ventilated critically ill patients. Crit Care. 2014 Dec 14;18(6):701. doi: 10.1186/s13054-014-0701-z.
PubMed 25499096Koekkoek WACK, van Setten CHC, Olthof LE, Kars JCNH, van Zanten ARH. Timing of PROTein INtake and clinical outcomes of adult critically ill patients on prolonged mechanical VENTilation: The PROTINVENT retrospective study. Clin Nutr. 2019 Apr;38(2):883-890. doi: 10.1016/j.clnu.2018.02.012. Epub 2018 Feb 17.
PubMed 29486907Arabi YM, Aldawood AS, Al-Dorzi HM, Tamim HM, Haddad SH, Jones G, McIntyre L, Solaiman O, Sakkijha MH, Sadat M, Mundekkadan S, Kumar A, Bagshaw SM, Mehta S; PermiT trial group. Permissive Underfeeding or Standard Enteral Feeding in High- and Low-Nutritional-Risk Critically Ill Adults. Post Hoc Analysis of the PermiT Trial. Am J Respir Crit Care Med. 2017 Mar 1;195(5):652-662. doi: 10.1164/rccm.201605-1012OC.
PubMed 27589411Heyland DK, Patel J, Bear D, Sacks G, Nixdorf H, Dolan J, Aloupis M, Licastro K, Jovanovic V, Rice TW, Compher C. The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-Based Randomized Trial: The EFFORT Trial. JPEN J Parenter Enteral Nutr. 2019 Mar;43(3):326-334. doi: 10.1002/jpen.1449. Epub 2018 Sep 27.
PubMed 30260486Arabi 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, Aldibaasi O, Sadat M, Jose J, Muharib D, Algethamy H, Al-Fares AA, Al-Hameed F, Mady A, Kharaba A, Al Bshabshe A, Maghrabi K, AlGhamdi K, Rasool G, AlGhamdi A, Almekhlafi GA, Chalabi J, AlHumedi HI, Sakkijha MH, Alamrey NK, Alaskar AS, Alhutail RH, Sifaoui K, Alqahtani R, Qureshi AS, Hejazi MM, Arishi H, AlQahtani S, Ghazi AM, Baaziz ST, Azhar AO, Alabbas SF, AlAqeely M, AlOrabi O, Al-Mutawa A, AlOtaibi M, Elghannam MF, Almaani M, Buabbas SF, Alfilfil WAM, Alshahrani MS, Starkopf J, Preiser JC, Perner A, AlMubarak JH, Hazem WM, Albrahim T, Al-Dawood A; and the Saudi Critical Care Trials Group. Statistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial. Trials. 2024 May 2;25(1):296. doi: 10.1186/s13063-024-08105-w.
PubMed 38698442Arabi YM, Al-Dorzi HM, Sadat M, Muharib D, Algethamy H, Al-Hameed F, Mady A, AlGhamdi A, Almekhlafi GA, Al-Fares AA, Kharaba A, Al Bshabshe A, Maghrabi K, Al Ghamdi K, Rasool G, Chalabi J, AlHumedi HI, Sakkijha MH, Alamrey NK, Alhutail RH, Sifaoui K, Almaani M, Alqahtani R, Qureshi AS, Hejazi MM, Arishi H, AlQahtani S, Ghazi AM, Baaziz ST, Azhar AO, Alabbas SF, AlAqeely M, AlOrabi O, Al-Mutawa A, AlOtaibi M, Aldibaasi O, Jose J, Starkopf J, Preiser JC, Perner A, Al-Dawood A; Saudi Critical Care Trials Group. Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: the REPLENISH randomized clinical trial protocol. Trials. 2023 Jul 30;24(1):485. doi: 10.1186/s13063-023-07507-6.
PubMed 37518058Al-Dorzi HM, Stapleton RD, Arabi YM. Nutrition priorities in obese critically ill patients. Curr Opin Clin Nutr Metab Care. 2022 Mar 1;25(2):99-109. doi: 10.1097/MCO.0000000000000803.
PubMed 34930871
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. 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: An International, Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04475666
- Acronym / sponsor ID
- REPLENISH / RC19/414/R
- Conditions
- Critical Illness, Nutrition Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,502 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 17 Jul 2020 (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.
The investigator will investigate the effect of supplemental enteral protein (1.2 g/kg/day) added to standard formula to achieve high amount of enteral protein (range 2-2.4 g/kg/day) given from ICU day 5 until ICU discharge up to ICU day 90 as compared to no supplemental enteral protein to achieve moderate amount enteral protein (0.8-1.2 g/kg/day), given in conjunction with similar amounts of stepwise caloric administration in the two groups on all-cause 90-day mortality.
Detailed description
The REPLENISH is a multicentric, international, open label, randomized controlled trial which will enroll subjects in intensive care unit. Patients will be randomized on day 4 of ICU admission. Until ICU day 4, protein requirement will be provided according to the local practice as long as no intravenous amino acids are given and the average protein intake in the first 4 days does not exceed 0.8 g/kg/day. On ICU day 4, patients will be randomized to one of the two treatment groups: one with standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula and another group will receive the standard amount of proteins (maximum 1.2 g/kg/day) from the primary polymeric formula AND supplemental protein at 1.2 g/kg/day.
Randomization will be stratified by suspected COVID-19 and then by site and the use of renal replacement therapy at the time of randomization (intermittent hemodialysis or continuous renal replacement therapy.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Replenish protein group | Active comparator | Other: Replenish protein groupThe subjects randomized to this group will receive the standard amount of proteins (maximum 1.2 g/kg/day) from the primary polymeric formula AND supplemental protein at 1.2 g/kg/day |
| Standard protein group | Active comparator | Other: Standard protein groupThe subjects randomized to this group will receive standard prescription without supplemental proteins (maximum1.2 g/kg/day) from the primary polymeric formula. No supplemental protein will be allowed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Lack of commitment to full life support or brain death. Patients with "Do Not Resuscitate" order but with commitment to ongoing life support can be enrolled.
- Patients on any amount of parenteral nutrition (PN) in ICU at the time of screening, whether PN is used alone or in combination with enteral nutrition. Non-nutritional calories (dextrose, propofol, citrate) not considered as PN.
- Patients who received an average protein of more than 0.8g/kg/day in the first 4 ICU days.
- Patients being fed entirely through oral route - i.e. those who are eating.
- Pregnancy.
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 protein groupFor patients with Body mass index(BMI) <30, use pre-ICU actual body weight(BW) for the calculation; if unavailable, use weight on ICU admission. For patients with BMI >=30, use adjusted body weight | Other | Replenish protein group |
| Standard protein groupFor patients with BMI <30, use pre-ICU actual BW for the calculation; if unavailable, use weight on ICU admission. For patients with BMI >=30, use adjusted body weight | Other | Standard protein group |
Primary outcome
90 day-all cause mortality
Time frame: 90 days
Mortality 90 days post randomization
5 secondary outcomes
Days alive at day 90 without life support
Time frame: 90 days
Days alive and out of hospital at day 90
Time frame: 90 days
Bacteremia until 2 days of ICU stay
Time frame: until 2 days post ICU.
New or progression of Skin Pressure Ulcers
Time frame: ICU stay
Functional assessment at day 90
Time frame: Day 90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 25733640Liebau F, Wernerman J, van Loon LJ, Rooyackers O. Effect of initiating enteral protein feeding on whole-body protein turnover in critically ill patients. Am J Clin Nutr. 2015 Mar;101(3):549-57. doi: 10.3945/ajcn.114.091934. Epub 2015 Feb 4.
- Background: 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.
- Background: PubMed 28098623Compher C, Chittams J, Sammarco T, Nicolo M, Heyland DK. Greater Protein and Energy Intake May Be Associated With Improved Mortality in Higher Risk Critically Ill Patients: A Multicenter, Multinational Observational Study. Crit Care Med. 2017 Feb;45(2):156-163. doi: 10.1097/CCM.0000000000002083.
- Background: PubMed 25499096Weijs PJ, Looijaard WG, Beishuizen A, Girbes AR, Oudemans-van Straaten HM. Early high protein intake is associated with low mortality and energy overfeeding with high mortality in non-septic mechanically ventilated critically ill patients. Crit Care. 2014 Dec 14;18(6):701. doi: 10.1186/s13054-014-0701-z.
- Background: PubMed 29486907Koekkoek WACK, van Setten CHC, Olthof LE, Kars JCNH, van Zanten ARH. Timing of PROTein INtake and clinical outcomes of adult critically ill patients on prolonged mechanical VENTilation: The PROTINVENT retrospective study. Clin Nutr. 2019 Apr;38(2):883-890. doi: 10.1016/j.clnu.2018.02.012. Epub 2018 Feb 17.
- Background: PubMed 27589411Arabi YM, Aldawood AS, Al-Dorzi HM, Tamim HM, Haddad SH, Jones G, McIntyre L, Solaiman O, Sakkijha MH, Sadat M, Mundekkadan S, Kumar A, Bagshaw SM, Mehta S; PermiT trial group. Permissive Underfeeding or Standard Enteral Feeding in High- and Low-Nutritional-Risk Critically Ill Adults. Post Hoc Analysis of the PermiT Trial. Am J Respir Crit Care Med. 2017 Mar 1;195(5):652-662. doi: 10.1164/rccm.201605-1012OC.
- Background: PubMed 30260486Heyland DK, Patel J, Bear D, Sacks G, Nixdorf H, Dolan J, Aloupis M, Licastro K, Jovanovic V, Rice TW, Compher C. The Effect of Higher Protein Dosing in Critically Ill Patients: A Multicenter Registry-Based Randomized Trial: The EFFORT Trial. JPEN J Parenter Enteral Nutr. 2019 Mar;43(3):326-334. doi: 10.1002/jpen.1449. Epub 2018 Sep 27.
- 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 38698442Arabi YM, Al-Dorzi HM, Aldibaasi O, Sadat M, Jose J, Muharib D, Algethamy H, Al-Fares AA, Al-Hameed F, Mady A, Kharaba A, Al Bshabshe A, Maghrabi K, AlGhamdi K, Rasool G, AlGhamdi A, Almekhlafi GA, Chalabi J, AlHumedi HI, Sakkijha MH, Alamrey NK, Alaskar AS, Alhutail RH, Sifaoui K, Alqahtani R, Qureshi AS, Hejazi MM, Arishi H, AlQahtani S, Ghazi AM, Baaziz ST, Azhar AO, Alabbas SF, AlAqeely M, AlOrabi O, Al-Mutawa A, AlOtaibi M, Elghannam MF, Almaani M, Buabbas SF, Alfilfil WAM, Alshahrani MS, Starkopf J, Preiser JC, Perner A, AlMubarak JH, Hazem WM, Albrahim T, Al-Dawood A; and the Saudi Critical Care Trials Group. Statistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial. Trials. 2024 May 2;25(1):296. doi: 10.1186/s13063-024-08105-w.
- Derived from this study: PubMed 37518058Arabi YM, Al-Dorzi HM, Sadat M, Muharib D, Algethamy H, Al-Hameed F, Mady A, AlGhamdi A, Almekhlafi GA, Al-Fares AA, Kharaba A, Al Bshabshe A, Maghrabi K, Al Ghamdi K, Rasool G, Chalabi J, AlHumedi HI, Sakkijha MH, Alamrey NK, Alhutail RH, Sifaoui K, Almaani M, Alqahtani R, Qureshi AS, Hejazi MM, Arishi H, AlQahtani S, Ghazi AM, Baaziz ST, Azhar AO, Alabbas SF, AlAqeely M, AlOrabi O, Al-Mutawa A, AlOtaibi M, Aldibaasi O, Jose J, Starkopf J, Preiser JC, Perner A, Al-Dawood A; Saudi Critical Care Trials Group. Replacing protein via enteral nutrition in a stepwise approach in critically ill patients: the REPLENISH randomized clinical trial protocol. Trials. 2023 Jul 30;24(1):485. doi: 10.1186/s13063-023-07507-6.
- Derived from this study: PubMed 34930871Al-Dorzi HM, Stapleton RD, Arabi YM. Nutrition priorities in obese critically ill patients. Curr Opin Clin Nutr Metab Care. 2022 Mar 1;25(2):99-109. doi: 10.1097/MCO.0000000000000803.
- Individual participant dataSharing planned: No
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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.
Yaseen M Arabi, MD principal investigator
King Saud Bin Abdulaziz University for Health Sciences
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 group and Standard protein group in people with Critical Illness and Nutrition Disorders, 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 0 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaseen M Arabi, MD (0118011111 ext. 18855, arabi@ngha.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90 day-all cause mortality (time frame: 90 days). 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 NCT04475666, which also lists 11 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 8 Sep 2025.