NCT04101071 (ASICS) is a NA clinical trial of Modular ketogenic feed in Critical Illness, sponsored by Barts & The London NHS Trust.

Who is sponsoring NCT04101071?

NCT04101071 is sponsored by Barts & The London NHS Trust.

What drugs are being tested in NCT04101071?

Interventions in NCT04101071: Modular ketogenic feed, Standard feed.

What condition does NCT04101071 study?

NCT04101071 studies Critical Illness.

Is NCT04101071 still recruiting?

NCT04101071 is currently completed. Last updated 1 August 2022.

Last reviewed 2022-08-01 · How we verify

NCT04101071: ASICS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Alternative Substrates in the Critically Ill Subject

Completed NA Last updated 1 August 2022

What this trial tests

NA trial testing Modular ketogenic feed in Critical Illness in 29 participants. Completed in 27 April 2022.

Timeline

2 October 2019

Primary endpoint
27 April 2022

27 April 2022

Quick facts

Lead sponsor	Barts & The London NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	29
Start date	2 October 2019
Primary completion	27 April 2022
Estimated completion	27 April 2022
Sites	2 locations across United Kingdom

Drugs / interventions tested

Modular ketogenic feed
Standard feed

Conditions studied

Critical Illness — all drugs for Critical Illness →

Sponsor

Barts & The London NHS Trust — full company profile →

Who can join

Adults 18 to 99, any sex, with Critical Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The over-arching aim of this study is to investigate the feasibility of administrating alternative substrates to intensive care unit (ICU) patients. This includes reconstituting and administering a modular ketone-inducing (ketogenic) enteral feeding regimen to ICU patients; to show that this feed does increase blood ketones; and that it is feasible to collect the desired outcomes. This will allow us to determine in a subsequent randomised controlled trial whether this intervention improves ICU outcomes (including ICU-related muscle loss).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Personalized nutrition therapy in critical care: 10 expert recommendations.
Wischmeyer PE, Bear DE, Berger MM, De Waele E, et al · · 2023 · cited 69× · PMID 37403125 · DOI 10.1186/s13054-023-04539-x
Persistent inflammation, immunosuppression, and catabolism syndrome (PICS): a review of definitions, potential therapies, and research priorities.
Chadda KR, Puthucheary Z. · · 2024 · cited 45× · PMID 38177003 · DOI 10.1016/j.bja.2023.11.052
A pilot study of alternative substrates in the critically Ill subject using a ketogenic feed.
McNelly A, Langan A, Bear DE, Page A, et al · · 2023 · cited 16× · PMID 38102152 · DOI 10.1038/s41467-023-42659-8
ESICM LIVES 2020.
· 2020 · cited 13× · PMID 33313986 · DOI 10.1186/s40635-020-00354-8
ESICM LIVES 2021: Part 1.
· 2021 · cited 6× · PMID 34633565 · DOI 10.1186/s40635-021-00413-8
Intensive Care Society State of the Art (SOA) 2022 Abstracts
· 2023
Alternative Substrates in the Critically Ill Subject (ASICS): Safety, Feasibility, Tolerability and Metabolic Profiling of a Novel Ketogenic Feed
McNelly A, Langan A, Bear DE, Page A, et al · · 2023 · DOI 10.1101/2023.03.30.23287849
41st International Symposium on Intensive Care and Emergency Medicine
· 2022

Verify or expand the search:

Other recruiting trials for Critical Illness

Currently open trials in the same condition.

NCT06189924 — Exhaled Breath Condensate Analysis in Mechanically Ventilated Patients · recruiting
NCT07418242 — Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients · recruiting
NCT07101640 — PK, Safety and Preliminary Efficacy Study of Montelukast in Critically Ill Infants With Developing Bronchopulmonary Dysp · Phase 1, PHASE2 · recruiting
NCT07177183 — Low Serum Creatinine as a Predictor of Prolonged Mechanical Ventilation and Weaning Failure · NA · recruiting
NCT07369258 — Clinical Application of Listening to Music to Prevent Delirium in the Intensive Care Unit · NA · recruiting

Other Barts & The London NHS Trust trials

Trials by the same sponsor.

NCT05753085 — Multimodality Optical and Ultrasound Intravascular Imaging for Stent Optimization and Atheroma Assessment · NA · withdrawn
NCT07047235 — Substrate Remodelling and Targeted Ablation in AF · NA · recruiting
NCT06871215 — Inflammation and Infective Endocarditis · withdrawn
NCT07076524 — MuScle WastIng and DysphaGia iN CriticAlly IlL Patients (SIGNAL) · recruiting
NCT06596486 — A Comparison of CoolStick With Ethyl Chloride for the Assessment of Light Touch · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04101071 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Barts & The London NHS Trust
Last refreshed: 1 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04101071.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing