Condition category
Signs and Symptoms
Date applied
03/05/2017
Date assigned
17/05/2017
Last edited
22/09/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Critical illness is a state in which patients depend on drugs or machines to support or replace organ function to keep them alive and allow them to heal. Such patients are admitted to intensive care units (ICU) to receive care. Critically ill patients are at risk of losing muscle power due to due to the natural breakdown of tissue from inactivity. Short term fasting may be beneficial in the recovery of disease. Even in ICU, withholding intravenous nutrition (nutrition delivered through a drip) for one week, surprisingly, avoids complications and allows severely ill patients to recover faster and go home earlier. This study is aiming to see if these beneficial effects can be broadened beyond the first week of critical illness. The aim of this study is to design a new fasting mimicking diet in ICU (ICU-FM) based on cyclic feeding interruptions and look at its effects.

Who can participate?
Adult patients in ICU who are unable to eat by mouth.

What does the study involve?
Participants are randomly allocated to undergo 12 hours of receiving nutrition through a drip or straight into the gut followed by 12 hours of fasting, or 12 hours of fasting followed by 12 hours of receiving nutrition through a drip or straight into the gut. If the 12 hour time period is judged to be insufficient, then the process is repeated using 24 hour time periods. At the start of the study and then after 12 or 24 hours (depending on the time period used), participants have samples of blood collected to assess their health. In addition, participants have their medical records reviewed after 7 and 90 days to assess survival rates.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.

Where is the study run from?
UZ Leuven (Belgium)

When is the study starting and how long is it expected to run for?
June 2016 to October 2017

Who is funding the study?
1. KU Leuven (Belgium)
2. Flanders Government FWO (Belgium)

Who is the main contact?
Dr Michael P. Casaer
michael.casaer@uzleuven.be

Trial website

http://gbiomed.kuleuven.be/english/research/50000618/50000663

Contact information

Type

Scientific

Primary contact

Prof Michael P. Casaer

ORCID ID

http://orcid.org/0000-0002-7087-0795

Contact details

Clincial Department of Intensive Care Medicine
UZ Leuven
Herestraat 49
Leuven
3000
Belgium
+32 16 34 87 86
michael.casaer@uzleuven.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ICU-FM-I-2016-1-1-2

Study information

Scientific title

ICU-FM: Implementation into the intensive care unit (ICU) of the beneficial effects of fasting (mimicking diets) (FM)

Acronym

ICU-FM-I

Study hypothesis

Twelve hours of nutrient restriction are sufficient to provoke a metabolic fasting response in critically ill patients, as reflected by increased plasma bilirubin and decreased insulin requirements.

Ethics approval

Commissie Medische Ethiek UZ KU Leuven , 27/07/2016, ref: B322201629914

Study design

Pilot randomised cross-over study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet. Available in Dutch and French.

Condition

Prolonged critical illness

Intervention

Participants are randomised by central computer in permuted blocks (size unknown to all involved) in a 1:1 ratio to either the 12/12 (or 24/24 if 12 hours would be not sufficient) caloric restriction (CR) regime followed by feeding or feeding followed by CR. All outcome assessors will be blinded for treatment allocation.

Nutritional targets will be achieved by EN±PN, as appropriate with a full feeding target of 20-25 kcal/kg ideal body weight, a dosage defined by age (< or > 60 years) and gender. During fasting intervals, no nutrition will be administered, unless spontaneous hypoglycemia occurs. The intervention is thus to infuse enteral and/or parenteral nutrition as required to achieve nutritional target during a 12 hours (or in faze 2: 24 hours) interval on ICU day 8. This is followed by a 12 hours or 24 hours fasting. The sequence of this metabolic cross over experiment is determined by randomization.

Plasma bilirubin, creatinine, BUN and glucose values and insulin requirements will be collected at study start, after the fasting window and after full feeding. Blood samples for evaluation of other changes in metabolism and cellular biology will be drawn likewise before and after the feeding and fasting interval.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Plasma bilirubin is measured by colorimetric assay in the Laboratory of Intensive Care Medicine at baseline and after the first and second intervention time window (12 hours or 24 hours according to the study phase)
2. Insulin requirements (total dose delivered over intervention time interval, this is the last 12 hours or 24 hours according to the study phase) are measured by reviewing the ICU-PDMS (Patient Data Management System [Metavision]) at baseline and after the first and the second intervention time window (this is after 12 hours and 24 hours in the first phase and eventually after 24 hours and 48 hours in the second phase of the study)

Secondary outcome measures

1. Mortality is measured using data from the National Registry via Hospital Clinical Work Station (KWS) at 90 days
2. New ICU-Morbidity occurring in the first week after randomization is assessed by reviewing the ICU-PDMS (Patient Data Management System [Metavision]) at baseline and 7 days

Overall trial start date

01/06/2016

Overall trial end date

01/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult ICU-patients
2. Unable to eat by mouth
3. Expected on day 7 to stay 3 more days in ICU

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70 patients (and possibly another 70 patients fasted for 24 hours if 12 hours is not sufficient)

Participant exclusion criteria

1. Patients with severe jaundice
2. Bilirubin > 5mg/dL, pregnant
3. Lactating patients

Recruitment start date

01/06/2017

Recruitment end date

01/10/2017

Locations

Countries of recruitment

Belgium

Trial participating centre

UZ Leuven
Clincial Department of Intensive Care Medicine Herestraat 49
Leuven
3000
Belgium

Sponsor information

Organisation

UZ Leuven

Sponsor details

Herestraat 49
Leuven
3000
Belgium

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

KU Leuven

Alternative name(s)

Katholieke Universiteit Leuven

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Belgium

Funder name

Flanders Government FWO

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results of this STEP-I pilot study will primarily serve the adequate design of ICU-FM-II, a clinical study exposing a larger group of patients to a longer time window of fasting mimicking versus normocaloric feeding. Publication of the results of this second study is planned in a high impact journal around 2019.

IPD Sharing plan:
The participant level data of this step I pilot metabolic cross over clinical experiment will not be publicly available. This would be a potential source of erroneous findings due to inadequate interpretation of the study design. The data will be stored in the research database of the Clinical Department and Laboratory of Intensive Care Medicine and request for post-hoc analyses with a clearly defined research question and methodology can be sent to the investigators. This approach to avoid misinterpretation of complex data and databases has been proposed in a recent summit on data-sharing organized by the NEJM in April 2017.

Intention to publish date

31/12/2019

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/09/2017: Internal review.