The CRISIS Prevention Study (CRISIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395161
Recruitment Status : Terminated (Terminated for futility on 11/30/09 based on the recommendation of the DSMB)
First Posted : November 2, 2006
Results First Posted : April 18, 2013
Last Update Posted : April 18, 2013
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Sepsis
Interventions: Drug: Metoclopramide
Drug: Zinc
Dietary Supplement: Glutamine
Drug: Selenium
Other: saline
Other: sterile water
Other: selenium
Dietary Supplement: whey-protein

  Participant Flow

  Baseline Characteristics

Population Description
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.

Reporting Groups
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

Baseline Measures
   Daily Nutriceutical Supplementation   Whey Protein   Total 
Overall Participants Analyzed 
[Units: Participants]
 149   144   293 
[Units: Participants]
<=18 years   149   144   293 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 7.9  (5.6)   8.4  (5.9)   8.1  (5.7) 
[Units: Participants]
Female   69   79   148 
Male   80   65   145 
Region of Enrollment 
[Units: Participants]
United States   149   144   293 
Immune Compromised at Study Entry [1] 
[Units: Participants]
Immune compromised   14   11   25 
Immune Competent   135   133   268 
[1] Patients were classified as immune compromised if they had acquired immunodeficiency syndrome, cancer, transplantation, primary immune deficiency or chronic immune suppressant therapy.

  Outcome Measures

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 ]

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

Certain Agreements:  
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
phone: 801-587-7753

Publications of Results:
Other Publications:
L Vankrieken. Immulite reproductive hormone assays: multicenter reference range data, 2000.
HG Friesen. Human prolactin. Ann Rev Coll Phys Surg Can, 11:275- 281, 1978.
LL Brunton. Agents affecting gastrointestinal water flux and motility. In Limbird LE Hardman JG, editor, Goodman and Gilman's The Pharmacological Basis of Therapeutics, pages 931-933. McGraw-Hill, New York, 9th edition, 1996.
F Shann, editor. Drug Doses. Collective Pty Ltd., Melbourne, 12th edition, 2003.
PR Dallman. White blood cells: developmental changes in numbers. In Ruolph CD Rudolph AM, Hoffman JIE, editor, Pediatrics, page 1061. Appleton and Lange, Norwalk CT, 19th edition, 1987.
Anonymous. Immunization in special clinical circumstances. In LK Pickering, editor, 2000 Redbook: Report of the Committee of Infectious Diseases, page 59. Academy of Pediatrics, Elk Grove Village, IL, 25th edition, 2000.
E.R. Stiehm. Immunologic disorders in infants and children. W.B. Saunders, Philadelphia, PA, 1989.

Responsible Party: Michael Dean, University of Utah Identifier: NCT00395161     History of Changes
Other Study ID Numbers: U01HD049934 ( U.S. NIH Grant/Contract )
First Submitted: October 31, 2006
First Posted: November 2, 2006
Results First Submitted: November 14, 2012
Results First Posted: April 18, 2013
Last Update Posted: April 18, 2013