The CRISIS Prevention Study
This study has been terminated.
(Terminated for futility on 11/30/09 based on the recommendation of the DSMB)
Seattle Children's Hospital
Children's Hospital Los Angeles
Arkansas Children's Hospital Research Institute
Children's Hospital of Michigan
University of Pittsburgh
Children's Research Institute
University of California, Los Angeles
Harborview Injury Prevention and Research Center
Information provided by (Responsible Party):
Michael Dean, University of Utah
First received: October 31, 2006
Last updated: April 16, 2013
Last verified: April 2013
Results First Received: November 14, 2012
|Study Design:||Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention|
Dietary Supplement: Glutamine
Other: sterile water
Dietary Supplement: whey-protein
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
|Dates of recruitment period: April 2007 - November 2009; Location: Pediatric Intensive Care Unit (PICU)|
|Significant events and approaches for the overall study following participant enrollment, but prior to group assignment|
|Patients were stratified according to immunocompromised status prior to randomization.|
|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide||Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.|
|Enteral Whey Protein, IV Saline||Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.|
Participant Flow: Overall Study
|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide||Enteral Whey Protein, IV Saline|
|Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.|
|No text entered.|
|Daily Nutriceutical Supplementation||Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.|
|Whey Protein||Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.|
|Total||Total of all reporting groups|
|Daily Nutriceutical Supplementation||Whey Protein||Total|
Number of Participants
|Between 18 and 65 years||0||0||0|
Mean (Standard Deviation)
|7.9 (5.6)||8.4 (5.9)||8.1 (5.7)|
Region of Enrollment
Immune Compromised at Study Entry
|||Patients were classified as immune compromised if they had acquired immunodeficiency syndrome, cancer, transplantation, primary immune deficiency or chronic immune suppressant therapy.|
|1. Primary:||The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters. [ Time Frame: 48 hours after admission until 5 days after discharged from the PICU ]|
|2. Secondary:||Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days [ Time Frame: 48 hours after PICU admission till discharge from PICU ]|
|3. Secondary:||Antibiotic-free Days [ Time Frame: 48 hours after admission until PICU discharge ]|
|4. Secondary:||Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days) [ Time Frame: from time of PICU admission till discharge from PICU ]|
|5. Secondary:||All-cause 28-day Mortality Rate. [ Time Frame: 28 days after admission to the PICU ]|
Limitations and Caveats
|Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data|
|The Data Safety Monitoring Board met on November 30, 2009. Interim analysis of the first 273 patients was presented. Per the Board's recommendations, the study was terminated based on futility.|
Results Point of Contact:
Publications of Results:
|Principal Investigators are NOT employed by the organization sponsoring the study.|
|There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.|
Results Point of Contact:
Name/Title: Jeri Burr, MS, RN-BC, CCRC
Organization: University of Utah
Organization: University of Utah
Publications of Results:
Carcillo JA, Dean JM, Holubkov R, Berger J, Meert KL, Anand KJ, Zimmerman J, Newth CJ, Harrison R, Burr J, Willson DF, Nicholson C; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Collaborative Pediatric Critical Care Research Network (CPCCRN). The randomized comparative pediatric critical illness stress-induced immune suppression (CRISIS) prevention trial. Pediatr Crit Care Med. 2012 Mar;13(2):165-73. doi: 10.1097/PCC.0b013e31823896ae.
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Carcillo J, Holubkov R, Dean JM, Berger J, Meert KL, Anand KJ, Zimmerman J, Newth CJ, Harrison R, Willson DF, Nicholson C; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Rationale and design of the pediatric critical illness stress-induced immune suppression (CRISIS) prevention trial. JPEN J Parenter Enteral Nutr. 2009 Jul-Aug;33(4):368-74. doi: 10.1177/0148607108327392. Epub 2009 Apr 14.
|Responsible Party:||Michael Dean, University of Utah|
|ClinicalTrials.gov Identifier:||NCT00395161 History of Changes|
|Other Study ID Numbers:||U01HD049934|
|Study First Received:||October 31, 2006|
|Results First Received:||November 14, 2012|
|Last Updated:||April 16, 2013|
|Health Authority:||United States: Food and Drug Administration