Trial · NCT00395161
The CRISIS Prevention Study
NCT00395161, Phase 3, Terminated, Michael Dean; results first posted 2013-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The CRISIS Prevention Study. Trials, record NCT00395161. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00395161
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The CRISIS Prevention Study
- NCT number
- NCT00395161
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 293 participants, actual
- Lead sponsor
- Michael Dean
- Conditions
- Sepsis
- Interventions
- Metoclopramide, Zinc, Glutamine, Selenium, saline, sterile water, selenium, whey-protein
- First posted
- 2006-11-02
- Last updated
- 2013-04-18
- Results first posted
- 2013-04-18
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | 48 hours after admission until 5 days after discharged from the PICU | |
| Secondary | Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days | 48 hours after PICU admission till discharge from PICU | |
| Secondary | Antibiotic-free Days | 48 hours after admission until PICU discharge | |
| Secondary | Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days) | from time of PICU admission till discharge from PICU | What is reported is the number of participants with counts qualifying as lymphopenia. |
| Secondary | All-cause 28-day Mortality Rate. | 28 days after admission to the PICU |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | 48 hours after admission until 5 days after discharged from the PICU | Intention to treat analysis of all randomized patients. | Days | MEDIAN |
| SECONDARY | Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days | 48 hours after PICU admission till discharge from PICU | All randomized patients analyzed by intention to treat | Mean number of events per 100 study days | MEAN |
| SECONDARY | Antibiotic-free Days | 48 hours after admission until PICU discharge | All randomized patients per intention to treat analysis | Days | MEDIAN |
| SECONDARY | Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days) | from time of PICU admission till discharge from PICU | All randomized patients (intention to treat analysis) | participants | NUMBER |
| SECONDARY | All-cause 28-day Mortality Rate. | 28 days after admission to the PICU | This safety outcome was analyzed by treatment received, among a total of 284 children who received treatment and had known 28-day status. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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. | Daily Nutriceutical Supplementation | 12.1 | 95% Confidence Interval 9.25 to 32.4 | Days | |
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. | Whey Protein | 13.2 | 95% Confidence Interval 10.8 to NA | Days | |
| Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days | Daily Nutriceutical Supplementation | 4.99 | 95% Confidence Interval 4.12 to 5.99 | Mean number of events per 100 study days | |
| Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days | Whey Protein | 4.83 | 95% Confidence Interval 4.01 to 5.77 | Mean number of events per 100 study days | |
| Antibiotic-free Days | Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide | 1 | Inter-Quartile Range 0 to 5 | Days | |
| Antibiotic-free Days | Enteral Whey Protein, IV Saline | 2 | Inter-Quartile Range 0 to 6 | Days | |
| Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days) | Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide | 5 | participants | ||
| Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days) | Enteral Whey Protein, IV Saline | 12 | participants | ||
| All-cause 28-day Mortality Rate. | Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide | 15 | participants | ||
| All-cause 28-day Mortality Rate. | Enteral Whey Protein, IV Saline | 8 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide | 149 | |
| Overall Study | STARTED | Enteral Whey Protein, IV Saline | 144 | |
| Overall Study | COMPLETED | Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide | 149 | |
| Overall Study | COMPLETED | Enteral Whey Protein, IV Saline | 144 | |
| Overall Study | NOT COMPLETED | Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide | 0 | |
| Overall Study | NOT COMPLETED | Enteral Whey Protein, IV Saline | 0 |
Source ClinicalTrials.gov
Adverse events258
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Daily Nutriceutical Supplementation | 9 | 148 | 10 |
| other | Anemia | Blood and lymphatic system disorders | Whey Protein | 10 | 139 | 11 |
| other | Coagulopathy | Blood and lymphatic system disorders | Daily Nutriceutical Supplementation | 8 | 148 | 8 |
| other | Coagulopathy | Blood and lymphatic system disorders | Whey Protein | 4 | 139 | 4 |
| other | Leukocytosis | Blood and lymphatic system disorders | Daily Nutriceutical Supplementation | 10 | 148 | 11 |
| other | Leukocytosis | Blood and lymphatic system disorders | Whey Protein | 10 | 139 | 10 |
| other | Bradycardia | Cardiac disorders | Daily Nutriceutical Supplementation | 17 | 148 | 19 |
| other | Bradycardia | Cardiac disorders | Whey Protein | 14 | 139 | 15 |
| other | Tachycardia | Cardiac disorders | Daily Nutriceutical Supplementation | 11 | 148 | 12 |
| other | Tachycardia | Cardiac disorders | Whey Protein | 20 | 139 | 24 |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Daily Nutriceutical Supplementation | ||
| Total, all-cause mortality | Whey Protein | ||
| Total, other adverse events | Daily Nutriceutical Supplementation | 119 | 148 |
| Total, other adverse events | Whey Protein | 112 | 139 |
| Total, serious adverse events | Daily Nutriceutical Supplementation | 73 | 148 |
| Total, serious adverse events | Whey Protein | 70 | 139 |
Source ClinicalTrials.gov
Papers67
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HD049934 | Data Coordinating Center for the Collaborative Pediatric Critical Care Research Network | DEAN, JONATHAN MICHAEL | UNIVERSITY OF UTAH | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2005 to 2020 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide vs Enteral Whey Protein, IV Saline: All-cause 28-day Mortality Rate. | Trial comparisons |
Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide vs Enteral Whey Protein, IV Saline: Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days) | Trial comparisons |
| Daily Nutriceutical Supplementation vs Whey Protein: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00395161
GET https://conductscience.org/api/trials/v1/NCT00395161/events?page=2