Evidence map›Paper›PMID 38698442›Full record

ArticleTrials2024

Statistical analysis plan for the replacing protein via enteral nutrition in a stepwise approach in critically ill patients (REPLENISH) randomized clinical trial.

Yaseen M Arabi, Hasan M Al-Dorzi, Omar Aldibaasi, Musharaf Sadat, Jesna Jose, Dina Muharib, Haifa Algethamy, Abdulrahman A Al-Fares, Fahad Al-Hameed, Ahmed Mady and 40 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04475666 (Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04475666 narecruitingnot on this map

Replacing Protein Via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients: An International, Multicenter Randomized Controlled Trial

TypeinterventionalSponsorKing Abdullah International Medical Research CenterRan2020 to 2026Enrolled2,502ConditionsCritical Illness, Nutrition DisordersArmsReplenish protein group, Standard protein group
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

50 authors.

Yaseen M ArabiIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. arabi@ngha.med.sa.ORCID http://orcid.org/0000-0001-5735-6241
Hasan M Al-DorziIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Omar AldibaasiKing Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Musharaf SadatIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Jesna JoseKing Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Dina MuharibIntensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.
Haifa AlgethamyDepartment of Anesthesia and Critical Care, King Abdulaziz University, King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
Abdulrahman A Al-FaresDepartment of Anesthesia, Critical Care Medicine and Pain Medicine, Al-Amiri Hospital, Ministry of Health, Kuwait City, Kuwait.
Fahad Al-HameedIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia.
Ahmed MadyIntensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.
Ayman KharabaPulmonary & Critical Care Departments, King Fahad Hospital, Critical Care Units- Madinah Region, Ministry of Health, Madinah, Saudi Arabia.
Ali Al BshabsheDepartment of Critical Care Medicine, Aseer Central Hospital, King Khalid University, Abha, Saudi Arabia.
Khalid MaghrabiInternal Medicine, Critical Care, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
Khalid AlGhamdiInternal Medicine, Critical Care, King Faisal Specialist Hospital and Research Centre, Jeddah, Saudi Arabia.
Ghulam RasoolDepartment of Anesthesiology and Surgical Intensive Care, Tanta University Hospitals, Tanta, Egypt.
Adnan AlGhamdiDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Ghaleb A AlmekhlafiDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Jamal ChalabiIntensive Care Department, King Abdulaziz Medical City, King Abdullah International Medical Research Center, AlAhsa Ministry of National Guard Health Affairs, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Haifaa Ibrahim AlHumediIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Maram Hasan SakkijhaIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Norah Khalid AlamreyIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Amjad Sami AlaskarIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Rabeah Hamad AlhutailDepartment of Intensive Care Services, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
Kaouthar SifaouiPulmonary & Critical Care Departments, King Fahad Hospital, Critical Care Units- Madinah Region, Ministry of Health, Madinah, Saudi Arabia.
Rakan AlqahtaniDepartment of Critical Care, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
Ahmad S QureshiIntensive Care Department, Prince Mohammed Bin Abdulaziz Hospital, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Madinah, Saudi Arabia.
Mohammed Moneer HejaziIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Hatim ArishiIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Samah AlQahtaniIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Amro Mohamed GhaziIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
Saleh T BaazizDepartment of Anesthesia and Critical Care, King Abdulaziz University, King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
Abeer Othman AzharDepartment of Anesthesia and Critical Care, King Abdulaziz University, King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
Sara Fahad AlabbasDepartment of Anesthesia and Critical Care, King Abdulaziz University, King Abdulaziz University Hospital, Jeddah, Saudi Arabia.
Mohammed AlAqeelyIntensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.
Ohoud AlOrabiIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, King Saud Bin Abdulaziz University for Health Sciences, Jeddah, Saudi Arabia.
Aliaa Al-MutawaDepartment of Anesthesia, Critical Care Medicine and Pain Medicine, Al-Amiri Hospital, Ministry of Health, Kuwait City, Kuwait.
Maha AlOtaibiIntensive Care Department, King Saud Medical City, Riyadh, Saudi Arabia.
Madiha Fawazy ElghannamInternal Medicine, Critical Care, King Faisal Specialist Hospital and Research Centre, Jeddah, Saudi Arabia.
Mohammed AlmaaniAdult Critical Care Services, King Fahad Medical City, Riyadh, Saudi Arabia.
Sarah Fadel BuabbasDepartment of Anesthesia, Critical Care and Pain Medicine, Jaber Al-Ahmed Al-Sabah Hospital, Kuwait City, Kuwait.
Wadiah Alawi M AlfilfilDepartment of Intensive Care, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia.
Mohammed S AlshahraniDepartment of Emergency and Critical Care, King Fahad Hospital of the University, Imam Abdulrahman Bin Faisal University, Al Khobar, Saudi Arabia.
Joel StarkopfClinic of Anaesthesiology and Intensive Care, University of Tartu, Tartu University Hospital, Tartu, Estonia.
Jean-Charles PreiserDepartment of Intensive Care, Erasme University Hospital, Brussels, Belgium.
Anders PernerDepartment of Intensive Care, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Jumana Hani AlMubarakDepartment of Anesthesia, Critical Care and Pain Medicine, Jaber Al-Ahmed Al-Sabah Hospital, Kuwait City, Kuwait.
Wafa Mansoor HazemDepartment of Intensive Care, Prince Mohammed Bin Abdulaziz Hospital, Riyadh, Saudi Arabia.
Talal AlbrahimDepartment of Emergency and Critical Care, King Fahad Hospital of the University, Imam Abdulrahman Bin Faisal University, Al Khobar, Saudi Arabia.
Abdulaziz Al-DawoodIntensive Care Department, King Abdulaziz Medical City, Ministry of National Guard Health Affairs, King Abdullah International Medical Research Center, ICU, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia.
and the Saudi Critical Care Trials Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal amount and timing of protein intake in critically ill patients are unknown. REPLENISH (Replacing Protein via Enteral Nutrition in a Stepwise Approach in Critically Ill Patients) trial evaluates whether supplemental enteral protein added to standard enteral nutrition to achieve a high amount of enteral protein given from ICU day five until ICU discharge or ICU day 90 as compared to no supplemental enteral protein to achieve a moderate amount of enteral protein would reduce all-cause 90-day mortality in adult critically ill mechanically ventilated patients.

methodsIn this multicenter randomized trial, critically ill patients will be randomized to receive supplemental enteral protein (1.2 g/kg/day) added to standard enteral nutrition to achieve a high amount of enteral protein (range of 2-2.4 g/kg/day) or no supplemental enteral protein to achieve a moderate amount of enteral protein (0.8-1.2 g/kg/day). The primary outcome is 90-day all-cause mortality; other outcomes include functional and health-related quality-of-life assessments at 90 days. The study sample size of 2502 patients will have 80% power to detect a 5% absolute risk reduction in 90-day mortality from 30 to 25%. Consistent with international guidelines, this statistical analysis plan specifies the methods for evaluating primary and secondary outcomes and subgroups. Applying this statistical analysis plan to the REPLENISH trial will facilitate unbiased analyses of clinical data.

conclusionEthics approval was obtained from the institutional review board, Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia (RC19/414/R). Approvals were also obtained from the institutional review boards of each participating institution. Our findings will be disseminated in an international peer-reviewed journal and presented at relevant conferences and meetings.

trial registrationClinicalTrials.gov, NCT04475666 . Registered on July 17, 2020.

Indexed as

Critical IllnessDietary ProteinsEnteral NutritionMulticenter Studies as TopicRandomized Controlled Trials as TopicData Interpretation, StatisticalHumansIntensive Care UnitsQuality of LifeRespiration, ArtificialTime FactorsTreatment OutcomeDietary ProteinsCritical illnessNutritionProteinRandomized clinical trialStatistical analysis plan

Identifiers

PMID38698442
PMCPMC11064302

What Socratic holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.