Critical IllnessPEPaNICNCT01536275
Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit
A study testing Late parenteral nutrition in people with Critical Illness and Children, run by KU Leuven at 3 sites in 3 countries.
Trial summary
In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Critical Illness, Children
- What is being tested?
- Late parenteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2012to Dec 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All patients admitted to the PICU with a STRONGkids score of 2 points or more upon ICU admission
Who cannot join
- Age of 17 years or older
- Patients with a DNR code at the time of ICU admission.
- Patients expected to die within 12 hours (=moribund patients).
- Patient readmitted to ICU after randomization to the PEPaNIC trial, more than 48 hours after the initial discharge
- Patients transferred from another paediatric intensive care after a stay of more than 7 days
- Patients suffering from ketoacidotic or hyperosmolar coma on admission.
Show all 11Show fewer
- Patients suffering from Short Bowel Syndrome on home PN or other conditions that require home PN
- Patients suspicious or established inborn metabolic diseases requiring specific diet
- STRONGkids score lower than 2 on ICU admission.
- Premature Newborns ( 37 weeks gestational age upon admission in the PICU)
- Prior inclusion in another randomized controlled outcome study
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients
In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition.
- Conditions
- Critical Illness, Children
- Being tested
- Late parenteral nutrition
- Keywords
- critical illness, children, nutrition, metabolism
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Late parenteral nutritionOther
Also called Late PN
Withholding parenteral nutrition during the first 7 days of ICU stay
| Study group | Role | What they receive |
|---|---|---|
| Early parenteral nutrition | No intervention | Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center |
| Late parenteral nutrition | Experimental | Parenteral nutrition will be withheld during the first 7 days of ICU stay Receives: Other: Late parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new infection during ICU stay
Measured: during ICU stay and up to 90 days post-randomization
Duration of ICU dependency (crude stay days and time to alive discharge from ICU)
Measured: during ICU stay and up to 90 days post-randomization
Secondary outcomes (15)
Mortality
Measured: during ICU stay, hospital stay and up to 90 days post-randomization
Time to alive discharge from hospital
Measured: during hospital stay and up to 90 days post-randomization
Incidence of hypoglycaemia during ICU stay
Measured: during the intervention window up to day 8 post-randomization
Time to final weaning from mechanical respiratory support
Measured: during ICU stay and up to 90 days post-randomization
Incidence of liver dysfunction during ICU stay
Measured: during ICU stay and up 90 days post-randomization
Need for haemodynamic support during ICU stay
Measured: during ICU stay and up 90 days post-randomization
Incidence of new kidney injury during ICU stay
Measured: during ICU stay and up 90 days post-randomization
Duration of antibiotics treatment during ICU stay
Measured: during ICU stay and up to 90 days post-randomization
Number of readmissions to the ICU
Measured: up to 90 days post-randomization
Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance
Measured: during the intervention window of 8 days and up to 90 days post-randomization
Markers of inflammation such as C-reactive protein concentrations during ICU stay
Measured: during ICU stay and up to 90 days post-randomization
Structural and or functional differences in muscle tissue during ICU stay
Measured: during ICU stay and up to 90 days post-randomization
biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples
with healthy matched control group
Measured: up to 4 years post-randomization
functional and neurocognitive development
with healthy matched control group
Measured: up to 4 years post-randomization
health economy analysis
total health care costs during hospital stay
Measured: during index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startJun 2012
- Primary completionMar 2016
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,440 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Sophia Kindergeneeskunde, Stollery Children's Hospital
- Responsible party
- Principal investigator, Greet Van den Berghe, KU Leuven
- Investigators
- Greet Van den Berghe, MD PhD, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536275
- Sponsor's protocol ID
- PEPaNIC
- Other IDs
- 2012-000811-10, ML8052, NL38772.000.12, IWT-TBM 110685
- Acronym
- PEPaNIC
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2012
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults. N Engl J Med. 2011 Aug 11;365(6):506-17. doi: 10.1056/NEJMoa1102662. Epub 2011 Jun 29.
PubMed 21714640Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.
PubMed 19176240Vanhorebeek I, Umman Serin N, Verbruggen SCAT, Joosten KFM, Van den Berghe G, Gunst J. Increased ureagenesis revealing metabolic intolerance to enhanced nutrition in the PICU: a secondary analysis of the PEPaNIC RCT. Crit Care. 2026 Sep 25;30(1):497. doi: 10.1186/s13054-026-06345-7.
PubMed 42791581Vanhorebeek I, Umman Serin N, Guiza F, Mebis L, Verbruggen SCAT, Joosten KFM, Van den Berghe G, Gunst J. Hypophosphatemia as a biomarker of metabolic intolerance to enhanced nutrition in the PICU: a secondary analysis of the PEPaNIC RCT. Crit Care. 2026 Feb 12;30(1):74. doi: 10.1186/s13054-026-05844-x.
PubMed 41680910Nakano FK, Dulfer K, Vanhorebeek I, Wouters PJ, Verbruggen SC, Joosten KF, Guiza Grandas F, Vens C, Van den Berghe G. Predicting adverse long-term neurocognitive outcomes after pediatric intensive care unit admission. Comput Methods Programs Biomed. 2024 Jun;250:108166. doi: 10.1016/j.cmpb.2024.108166. Epub 2024 Apr 10.
PubMed 38614026Veldscholte K, Hulst JM, Eveleens RD, de Jonge RCJ, de Koning BAE, van den Berg SAA, van der Wal R, Ruijter GJG, Rizopoulos D, Vanhorebeek I, Gunst J, Casaer M, Van den Berghe G, Joosten KFM, Verbruggen SCAT. Gastrointestinal Biomarkers and Their Association with Feeding in the First Five Days of Pediatric Critical Illness. J Pediatr Gastroenterol Nutr. 2023 Dec 1;77(6):811-818. doi: 10.1097/MPG.0000000000003950. Epub 2023 Sep 20.
PubMed 37728917Verlinden I, Coppens G, Vanhorebeek I, Guiza F, Derese I, Wouters PJ, Joosten KF, Verbruggen SC, Van den Berghe G. Long-term impact of paediatric critical illness on the difference between epigenetic and chronological age in relation to physical growth. Clin Epigenetics. 2023 Jan 14;15(1):8. doi: 10.1186/s13148-023-01424-w.
PubMed 36639798Coppens G, Vanhorebeek I, Verlinden I, Derese I, Wouters PJ, Joosten KF, Verbruggen SC, Guiza F, Van den Berghe G. Assessment of aberrant DNA methylation two years after paediatric critical illness: a pre-planned secondary analysis of the international PEPaNIC trial. Epigenetics. 2023 Dec;18(1):2146966. doi: 10.1080/15592294.2022.2146966. Epub 2022 Nov 16.
PubMed 36384393Vanhorebeek I, Jacobs A, Mebis L, Dulfer K, Eveleens R, Van Cleemput H, Wouters PJ, Verlinden I, Joosten K, Verbruggen S, Van den Berghe G. Impact of critical illness and withholding of early parenteral nutrition in the pediatric intensive care unit on long-term physical performance of children: a 4-year follow-up of the PEPaNIC randomized controlled trial. Crit Care. 2022 May 12;26(1):133. doi: 10.1186/s13054-022-04010-3.
PubMed 35549984Verlinden I, Guiza F, Dulfer K, Van Cleemput H, Wouters PJ, Guerra GG, Joosten KF, Verbruggen SC, Vanhorebeek I, Van den Berghe G. Physical, Emotional/Behavioral, and Neurocognitive Developmental Outcomes From 2 to 4 Years After PICU Admission: A Secondary Analysis of the Early Versus Late Parenteral Nutrition Randomized Controlled Trial Cohort. Pediatr Crit Care Med. 2022 Aug 1;23(8):580-592. doi: 10.1097/PCC.0000000000002971. Epub 2022 May 9.
PubMed 35522534Jacobs A, Guiza F, Verlinden I, Dulfer K, Garcia Guerra G, Joosten K, Verbruggen SC, Vanhorebeek I, Van den Berghe G. Differential DNA methylation by early versus late parenteral nutrition in the PICU: a biological basis for its impact on emotional and behavioral problems documented 4 years later. Clin Epigenetics. 2021 Jul 27;13(1):146. doi: 10.1186/s13148-021-01124-3.
PubMed 34315515Verlinden I, Dulfer K, Vanhorebeek I, Guiza F, Hordijk JA, Wouters PJ, Guerra GG, Joosten KF, Verbruggen SC, Van den Berghe G. Role of age of critically ill children at time of exposure to early or late parenteral nutrition in determining the impact hereof on long-term neurocognitive development: A secondary analysis of the PEPaNIC-RCT. Clin Nutr. 2021 Mar;40(3):1005-1012. doi: 10.1016/j.clnu.2020.07.004. Epub 2020 Jul 14.
PubMed 32758384Jacobs A, Dulfer K, Eveleens RD, Hordijk J, Van Cleemput H, Verlinden I, Wouters PJ, Mebis L, Guerra GG, Joosten K, Verbruggen SC, Guiza F, Vanhorebeek I, Van den Berghe G. Long-term developmental effect of withholding parenteral nutrition in paediatric intensive care units: a 4-year follow-up of the PEPaNIC randomised controlled trial. Lancet Child Adolesc Health. 2020 Jul;4(7):503-514. doi: 10.1016/S2352-4642(20)30104-8.
PubMed 32562632Hordijk J, Verbruggen S, Vanhorebeek I, Guiza F, Wouters P, Van den Berghe G, Joosten K, Dulfer K. Health-related quality of life of children and their parents 2 years after critical illness: pre-planned follow-up of the PEPaNIC international, randomized, controlled trial. Crit Care. 2020 Jun 16;24(1):347. doi: 10.1186/s13054-020-03059-2.
PubMed 32546247van Puffelen E, Hulst JM, Vanhorebeek I, Dulfer K, Van den Berghe G, Joosten KFM, Verbruggen SCAT. Effect of late versus early initiation of parenteral nutrition on weight deterioration during PICU stay: Secondary analysis of the PEPaNIC randomised controlled trial. Clin Nutr. 2020 Jan;39(1):104-109. doi: 10.1016/j.clnu.2019.02.014. Epub 2019 Mar 4.
PubMed 30879734
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01536275
- Acronym / sponsor ID
- PEPaNIC / PEPaNIC
- Conditions
- Critical Illness, Children
- Keywords
- critical illness, children, nutrition, metabolism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,440 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Sophia Kindergeneeskunde, Stollery Children's Hospital
- Study start
- Jun 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Feb 2012 (estimated)
- 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.
In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early parenteral nutrition | No intervention | –Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center |
| Late parenteral nutrition | Experimental | Other: Late parenteral nutritionParenteral nutrition will be withheld during the first 7 days of ICU stay |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients admitted to the PICU with a STRONGkids score of 2 points or more upon ICU admission
Key exclusion criteria (11 listed)
- Age of 17 years or older
- Patients with a DNR code at the time of ICU admission.
- Patients expected to die within 12 hours (=moribund patients).
- Patient readmitted to ICU after randomization to the PEPaNIC trial, more than 48 hours after the initial discharge
- Patients transferred from another paediatric intensive care after a stay of more than 7 days
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 |
|---|---|---|
| Late parenteral nutritionAlso: Late PNWithholding parenteral nutrition during the first 7 days of ICU stay | Other | Late parenteral nutrition |
Primary outcome
Incidence of new infection during ICU stay
Time frame: during ICU stay and up to 90 days post-randomization
Duration of ICU dependency (crude stay days and time to alive discharge from ICU)
Time frame: during ICU stay and up to 90 days post-randomization
15 secondary outcomes
Mortality
Time frame: during ICU stay, hospital stay and up to 90 days post-randomization
Time to alive discharge from hospital
Time frame: during hospital stay and up to 90 days post-randomization
Incidence of hypoglycaemia during ICU stay
Time frame: during the intervention window up to day 8 post-randomization
Time to final weaning from mechanical respiratory support
Time frame: during ICU stay and up to 90 days post-randomization
Incidence of liver dysfunction during ICU stay
Time frame: during ICU stay and up 90 days post-randomization
Need for haemodynamic support during ICU stay
Time frame: during ICU stay and up 90 days post-randomization
Incidence of new kidney injury during ICU stay
Time frame: during ICU stay and up 90 days post-randomization
Duration of antibiotics treatment during ICU stay
Time frame: during ICU stay and up to 90 days post-randomization
Number of readmissions to the ICU
Time frame: up to 90 days post-randomization
Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance
Time frame: during the intervention window of 8 days and up to 90 days post-randomization
Markers of inflammation such as C-reactive protein concentrations during ICU stay
Time frame: during ICU stay and up to 90 days post-randomization
Structural and or functional differences in muscle tissue during ICU stay
Time frame: during ICU stay and up to 90 days post-randomization
biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples
Time frame: up to 4 years post-randomization
functional and neurocognitive development
Time frame: up to 4 years post-randomization
health economy analysis
Time frame: during index hospitalization
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 12 Feb 2024.
- Background: PubMed 21714640Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults. N Engl J Med. 2011 Aug 11;365(6):506-17. doi: 10.1056/NEJMoa1102662. Epub 2011 Jun 29.
- Background: PubMed 19176240Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.
- Derived from this study: PubMed 42791581Vanhorebeek I, Umman Serin N, Verbruggen SCAT, Joosten KFM, Van den Berghe G, Gunst J. Increased ureagenesis revealing metabolic intolerance to enhanced nutrition in the PICU: a secondary analysis of the PEPaNIC RCT. Crit Care. 2026 Sep 25;30(1):497. doi: 10.1186/s13054-026-06345-7.
- Derived from this study: PubMed 41680910Vanhorebeek I, Umman Serin N, Guiza F, Mebis L, Verbruggen SCAT, Joosten KFM, Van den Berghe G, Gunst J. Hypophosphatemia as a biomarker of metabolic intolerance to enhanced nutrition in the PICU: a secondary analysis of the PEPaNIC RCT. Crit Care. 2026 Feb 12;30(1):74. doi: 10.1186/s13054-026-05844-x.
- Derived from this study: PubMed 38614026Nakano FK, Dulfer K, Vanhorebeek I, Wouters PJ, Verbruggen SC, Joosten KF, Guiza Grandas F, Vens C, Van den Berghe G. Predicting adverse long-term neurocognitive outcomes after pediatric intensive care unit admission. Comput Methods Programs Biomed. 2024 Jun;250:108166. doi: 10.1016/j.cmpb.2024.108166. Epub 2024 Apr 10.
- Derived from this study: PubMed 37728917Veldscholte K, Hulst JM, Eveleens RD, de Jonge RCJ, de Koning BAE, van den Berg SAA, van der Wal R, Ruijter GJG, Rizopoulos D, Vanhorebeek I, Gunst J, Casaer M, Van den Berghe G, Joosten KFM, Verbruggen SCAT. Gastrointestinal Biomarkers and Their Association with Feeding in the First Five Days of Pediatric Critical Illness. J Pediatr Gastroenterol Nutr. 2023 Dec 1;77(6):811-818. doi: 10.1097/MPG.0000000000003950. Epub 2023 Sep 20.
- Derived from this study: PubMed 36639798Verlinden I, Coppens G, Vanhorebeek I, Guiza F, Derese I, Wouters PJ, Joosten KF, Verbruggen SC, Van den Berghe G. Long-term impact of paediatric critical illness on the difference between epigenetic and chronological age in relation to physical growth. Clin Epigenetics. 2023 Jan 14;15(1):8. doi: 10.1186/s13148-023-01424-w.
- Derived from this study: PubMed 36384393Coppens G, Vanhorebeek I, Verlinden I, Derese I, Wouters PJ, Joosten KF, Verbruggen SC, Guiza F, Van den Berghe G. Assessment of aberrant DNA methylation two years after paediatric critical illness: a pre-planned secondary analysis of the international PEPaNIC trial. Epigenetics. 2023 Dec;18(1):2146966. doi: 10.1080/15592294.2022.2146966. Epub 2022 Nov 16.
- Derived from this study: PubMed 35549984Vanhorebeek I, Jacobs A, Mebis L, Dulfer K, Eveleens R, Van Cleemput H, Wouters PJ, Verlinden I, Joosten K, Verbruggen S, Van den Berghe G. Impact of critical illness and withholding of early parenteral nutrition in the pediatric intensive care unit on long-term physical performance of children: a 4-year follow-up of the PEPaNIC randomized controlled trial. Crit Care. 2022 May 12;26(1):133. doi: 10.1186/s13054-022-04010-3.
- Derived from this study: PubMed 35522534Verlinden I, Guiza F, Dulfer K, Van Cleemput H, Wouters PJ, Guerra GG, Joosten KF, Verbruggen SC, Vanhorebeek I, Van den Berghe G. Physical, Emotional/Behavioral, and Neurocognitive Developmental Outcomes From 2 to 4 Years After PICU Admission: A Secondary Analysis of the Early Versus Late Parenteral Nutrition Randomized Controlled Trial Cohort. Pediatr Crit Care Med. 2022 Aug 1;23(8):580-592. doi: 10.1097/PCC.0000000000002971. Epub 2022 May 9.
- Derived from this study: PubMed 34315515Jacobs A, Guiza F, Verlinden I, Dulfer K, Garcia Guerra G, Joosten K, Verbruggen SC, Vanhorebeek I, Van den Berghe G. Differential DNA methylation by early versus late parenteral nutrition in the PICU: a biological basis for its impact on emotional and behavioral problems documented 4 years later. Clin Epigenetics. 2021 Jul 27;13(1):146. doi: 10.1186/s13148-021-01124-3.
- Derived from this study: PubMed 32758384Verlinden I, Dulfer K, Vanhorebeek I, Guiza F, Hordijk JA, Wouters PJ, Guerra GG, Joosten KF, Verbruggen SC, Van den Berghe G. Role of age of critically ill children at time of exposure to early or late parenteral nutrition in determining the impact hereof on long-term neurocognitive development: A secondary analysis of the PEPaNIC-RCT. Clin Nutr. 2021 Mar;40(3):1005-1012. doi: 10.1016/j.clnu.2020.07.004. Epub 2020 Jul 14.
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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. This study is not recruiting at the moment.
Greet Van den Berghe, MD PhD principal investigator
KU Leuven
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Late parenteral nutrition in people with Critical Illness and Children, run by KU Leuven at 3 sites in 3 countries.
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 1 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Canada, Netherlands. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new infection during ICU stay (time frame: during ICU stay and up to 90 days post-randomization). The study lists 2 primary outcomes in all. 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 NCT01536275, which also lists 21 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 12 Feb 2024.