An interventional study of Replenish Protein and Standard protein in Critical Illness, ARDS and Septic Shock, sponsored by King Abdullah International Medical Research Center. Completed at 2 sites in Saudi Arabia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by King Abdullah International Medical Research Center · Not applicable, Interventional, and Other
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.
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
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
This study's enrollment of 40 is below the median of 79 across 636 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →King Abdullah International Medical Research Center is the lead sponsor of 46 studies on the registry; 6 are open to participants now.
Compared within Shock, Septic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Lack of commitment to ongoing life support, which includes;
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;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Replenish Protein
Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14
Dietary Supplement: Standard 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.
Also known as: Intervention group
Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14
Also known as: Control group
Recruitment
Recruitment log
Time frame: 6 months
Retention rate
withdrawals
Time frame: 14 days
Achieved protein intake
Feeding data
Time frame: 14 days
Plan to share: 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
Ran from May 2018 to primary completion in May 2019, 11 months.
Of 164 non-industry interventional studies with no phase under Shock, Septic, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 41. This study's 11 months is below that.
Counting every sponsor, half of 172 studies reached it within 25 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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King Abdullah International Medical Research Center