SepsisPhase 3CRISISNCT00395161
The CRISIS Prevention Study
A Phase 3 study testing Metoclopramide, Zinc and Glutamine in people with Sepsis, run by Michael Dean at 7 sites in United States.
Trial summary
Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Metoclopramide, Zinc and Glutamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 293 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2007to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- During the initial accrual period for this study, prior to the first interim analysis, patients will be eligible for enrollment if they:
- are between 12 months and less than 18 years; AND
- are within the first 48 hours of the PICU admission; AND
- have an endotracheal tube, central venous catheter (new or old, tunneled or not tunneled), or Foley catheter; AND
- are anticipated to have an indwelling arterial or central venous catheter for blood sampling during the first three days of study enrollment.
- After the Data Safety Monitoring Board (DSMB) conducts its first interim evaluation, after enrollment of approximately 200 subjects, a decision will be made by the DSMB concerning enrollment of subjects between 40 weeks gestational age and 12 months. If the DSMB approves enrollment of infants after the first interim analysis, then patients will be eligible for enrollment if they:
Show all 10Show fewer
- are between 40 weeks gestational age and less than 18 years; AND
- are within the first 48 hours of the PICU admission; AND
- have an endotracheal tube, central venous catheter (new or old, tunneled or not tunneled), or Foley catheter; AND
- are anticipated to have an indwelling arterial or central venous catheter for blood sampling during the first three days of study enrollment.
Who cannot join
- During the initial accrual period for this study, prior to the first interim analysis, patients will be ineligible for enrollment if ANY of the following is true or anticipated:
- are less than 1 year age; OR
- are greater than or equal to 18 years of age; OR
- have a known allergy to metoclopramide; OR
- planned removal of endotracheal tube, central venous catheter, AND Foley catheters, within 72 hours of study enrollment, OR
- suspected intestinal obstruction, OR
Show all 18Show fewer
- intestinal surgery or bowel disruption, OR
- chronic metoclopramide therapy prior to enrollment, OR
- failure to enroll within 48 hours of PICU admission, OR
- readmission to PICU in the previous 28 days, OR
- previously enrolled in this study, OR
- lack of commitment to aggressive intensive care therapies.
- After the Data Safety Monitoring Board (DSMB) conducts its first interim evaluation, after enrollment of approximately 200 subjects, a decision will be made by the DSMB concerning enrollment of subjects between 40 weeks gestational age and 12 months. If the DSMB approves enrollment of infants after the first interim analysis, then patients will be ineligible for enrollment if ANY of the following is true or anticipated:
- are less than 40 weeks gestational age; OR
- are greater than or equal to 18 years of age; OR
- have a known allergy to metoclopramide; OR
- planned removal of endotracheal tube, central venous catheter, AND Foley catheters, within 72 hours of study enrollment, OR
- suspected intestinal obstruction
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Children's Hospital of Michigan
Detroit, Michigan, 48201
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Childrens Hospital of Los Angeles
Los Angeles, California, 90027
University of California Los Angeles Medical Center
Los Angeles, California, 90095
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Seattle Children's Hospital
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: The Critical Illness Stress-induced Immune Suppression Prevention Trial
Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. This study will use a double-blind, randomized, controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill children.
Read the detailed description
Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. Presently, "prophylaxis" strategies are used to prevent stress-induced gastrointestinal bleeding; however, no "prophylaxis" strategy is used to prevent stress-induced nosocomial infection and sepsis. When left unopposed, the stress hormone, cortisol, induces lymphocyte apoptosis, lymphopenia, and immune insufficiency. Prolactin is the counter-regulatory stress hormone that prevents cortisol-induced apoptosis and immunosuppression. Zinc, selenium, and glutamine are also important in maintenance of lymphocyte health. Critically ill patients commonly develop hypoprolactinemia secondary to increased central nervous system dopaminergic activity, as well as zinc, selenium, and glutamine deficiency caused by increased utilization and decreased supply. Hypoprolactinemia can be prevented by metoclopramide, a dopamine 2 receptor antagonist commonly used as a prokinetic in children, and zinc, selenium, and glutamine deficiency can be prevented with enteral supplementation. This study will use a double-blind randomized controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill children.
- Conditions
- Sepsis
- Being tested
- Metoclopramide, Zinc, Glutamine, Selenium, saline
- Keywords
- sepsis, prevention, mineral supplementation
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Also called Reglan
0.2 mg/kg/dose IV every 12 hours
ZincDrug
one enteral dose daily of zinc chloride (10 mg/day elemental zinc for infants < or equal to one year of age, and 20 mg/day elemental zinc for patients > 1 year of age)
GlutamineDietary supplement
one enteral dose daily of glutamine 0.3 gm/kg/day
SeleniumDrug
one enteral dose daily of selenium (40 μg for infants < 8 months of age, 60 μg for infants 8 to 12 months of age, 90 μg for children 1-3 years, 150 μg for children 4-8 years, 280 μg for children 9 to 13 years, and 400 μg for children > 13 years)
salineOther
equivalent volume of intravenous saline
sterile waterOther
equivalent volume of sterile water
seleniumOther
equivalent volume of sterile water
whey-proteinDietary supplement
Also called Beneprotein
one enteral dose daily of whey-protein
| Study group | Role | What they receive |
|---|---|---|
| zinc selenium glutamine metoclopramide | Experimental | metoclopramide, zinc, selenium, and glutamine Receives: Drug: Metoclopramide; Drug: Zinc; Dietary Supplement: Glutamine; Drug: Selenium |
| enteral whey protein and IV saline | Placebo comparator | saline, sterile water, whey protein Receives: Other: saline; Other: sterile water; Other: selenium; Dietary Supplement: whey-protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 hours after admission until 5 days after discharged from the PICU
Secondary outcomes (4)
Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days
Measured: 48 hours after PICU admission till discharge from PICU
Antibiotic-free Days
Measured: 48 hours after admission until PICU discharge
Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days)
What is reported is the number of participants with counts qualifying as lymphopenia.
Measured: from time of PICU admission till discharge from PICU
All-cause 28-day Mortality Rate.
Measured: 28 days after admission to the PICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startApr 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Terminated for futility on 11/30/09 based on the recommendation of the DSMB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (74)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Dean
- Sponsor type
- University, hospital or other
- Collaborators
- 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 National Research Institute, University of California, Los Angeles, Harborview Injury Prevention and Research Center
- Responsible party
- Sponsor-investigator, Michael Dean, University of Utah
- Investigators
- Joseph Carcillo, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395161
- Sponsor's protocol ID
- U01HD049934
- Acronym
- CRISIS
- Status last verified
- Apr 2013
- First submitted
- 31 Oct 2006
- Last updated
- 18 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Watson RS, Carcillo JA, Linde-Zwirble WT, Clermont G, Lidicker J, Angus DC. The epidemiology of severe sepsis in children in the United States. Am J Respir Crit Care Med. 2003 Mar 1;167(5):695-701. doi: 10.1164/rccm.200207-682OC. Epub 2002 Nov 14.
PubMed 12433670Brown RB, Stechenberg B, Sands M, Hosmer D, Ryczak M. Infections in a pediatric intensive care unit. Am J Dis Child. 1987 Mar;141(3):267-70. doi: 10.1001/archpedi.1987.04460030045021.
PubMed 3812407Stein F, Trevino R. Nosocomial infections in the pediatric intensive care unit. Pediatr Clin North Am. 1994 Dec;41(6):1245-57. doi: 10.1016/s0031-3955(16)38871-x.
PubMed 7984384Ford-Jones EL, Mindorff CM, Pollock E, Milner R, Bohn D, Edmonds J, Barker G, Gold R. Evaluation of a new method of detection of nosocomial infection in the pediatric intensive care unit: the Infection Control Sentinel Sheet System. Infect Control Hosp Epidemiol. 1989 Nov;10(11):515-20. doi: 10.1086/645938.
PubMed 2685101Milliken J, Tait GA, Ford-Jones EL, Mindorff CM, Gold R, Mullins G. Nosocomial infections in a pediatric intensive care unit. Crit Care Med. 1988 Mar;16(3):233-7. doi: 10.1097/00003246-198803000-00005.
PubMed 3277780Allen U, Ford-Jones EL. Nosocomial infections in the pediatric patient: an update. Am J Infect Control. 1990 Jun;18(3):176-93. doi: 10.1016/0196-6553(90)90183-s.
PubMed 2194407Donowitz LG. High risk of nosocomial infection in the pediatric critical care patient. Crit Care Med. 1986 Jan;14(1):26-8. doi: 10.1097/00003246-198601000-00006.
PubMed 3510104Meakins JL, Pietsch JB, Bubenick O, Kelly R, Rode H, Gordon J, MacLean LD. Delayed hypersensitivity: indicator of acquired failure of host defenses in sepsis and trauma. Ann Surg. 1977 Sep;186(3):241-50. doi: 10.1097/00000658-197709000-00002.
PubMed 142452Pellegrini JD, De AK, Kodys K, Puyana JC, Furse RK, Miller-Graziano C. Relationships between T lymphocyte apoptosis and anergy following trauma. J Surg Res. 2000 Feb;88(2):200-6. doi: 10.1006/jsre.1999.5797.
PubMed 10644489O'Sullivan ST, Lederer JA, Horgan AF, Chin DH, Mannick JA, Rodrick ML. Major injury leads to predominance of the T helper-2 lymphocyte phenotype and diminished interleukin-12 production associated with decreased resistance to infection. Ann Surg. 1995 Oct;222(4):482-90; discussion 490-2. doi: 10.1097/00000658-199522240-00006.
PubMed 7574928Menges T, Engel J, Welters I, Wagner RM, Little S, Ruwoldt R, Wollbrueck M, Hempelmann G. Changes in blood lymphocyte populations after multiple trauma: association with posttraumatic complications. Crit Care Med. 1999 Apr;27(4):733-40. doi: 10.1097/00003246-199904000-00026.
PubMed 10321662Gogos CA, Drosou E, Bassaris HP, Skoutelis A. Pro- versus anti-inflammatory cytokine profile in patients with severe sepsis: a marker for prognosis and future therapeutic options. J Infect Dis. 2000 Jan;181(1):176-80. doi: 10.1086/315214.
PubMed 10608764Rathmell JC, Thompson CB. Pathways of apoptosis in lymphocyte development, homeostasis, and disease. Cell. 2002 Apr;109 Suppl:S97-107. doi: 10.1016/s0092-8674(02)00704-3.
PubMed 11983156Fletcher-Chiappini SE, Compton MM, LaVoie HA, Day EB, Witorsch RJ. Glucocorticoid-prolactin interactions in Nb2 lymphoma cells: antiproliferative versus anticytolytic effects. Proc Soc Exp Biol Med. 1993 Mar;202(3):345-52. doi: 10.3181/00379727-202-43545.
PubMed 8437991Ayala A, Herdon CD, Lehman DL, DeMaso CM, Ayala CA, Chaudry IH. The induction of accelerated thymic programmed cell death during polymicrobial sepsis: control by corticosteroids but not tumor necrosis factor. Shock. 1995 Apr;3(4):259-67. doi: 10.1097/00024382-199504000-00003.
PubMed 7600193
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Critical Illness Stress-induced Immune Suppression Prevention Trial
- ClinicalTrials.gov ID
- NCT00395161
- Acronym / sponsor ID
- CRISIS / U01HD049934
- Conditions
- Sepsis
- Keywords
- sepsis, prevention, mineral supplementation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated for futility on 11/30/09 based on the recommendation of the DSMB
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Michael DeanUniversity, hospital or other
- Collaborators
- 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 National Research Institute, University of California, Los Angeles, Harborview Injury Prevention and Research Center
- Study start
- Apr 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 2 Nov 2006 (estimated)
- Results
- Posted 18 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. This study will use a double-blind, randomized, controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill children.
Detailed description
Despite strict hand washing, sterile technique, and antibiotic-coated catheters, nosocomial infection and sepsis remain the leading acquired causes of morbidity and mortality in critically ill children. Subsequent use of antibiotics to treat nosocomial infection and sepsis is considered a major attributable factor in the rise of antibiotic-resistant organisms in this population of children. Presently, "prophylaxis" strategies are used to prevent stress-induced gastrointestinal bleeding; however, no "prophylaxis" strategy is used to prevent stress-induced nosocomial infection and sepsis. When left unopposed, the stress hormone, cortisol, induces lymphocyte apoptosis, lymphopenia, and immune insufficiency. Prolactin is the counter-regulatory stress hormone that prevents cortisol-induced apoptosis and immunosuppression. Zinc, selenium, and glutamine are also important in maintenance of lymphocyte health. Critically ill patients commonly develop hypoprolactinemia secondary to increased central nervous system dopaminergic activity, as well as zinc, selenium, and glutamine deficiency caused by increased utilization and decreased supply. Hypoprolactinemia can be prevented by metoclopramide, a dopamine 2 receptor antagonist commonly used as a prokinetic in children, and zinc, selenium, and glutamine deficiency can be prevented with enteral supplementation. This study will use a double-blind randomized controlled trial design to test the hypothesis that daily prophylaxis with metoclopramide, zinc, selenium and glutamine will reduce nosocomial infection and sepsis in critically ill children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zinc selenium glutamine metoclopramide | Experimental | Drug: Metoclopramide, Drug: Zinc, Dietary Supplement: Glutamine, Drug: Seleniummetoclopramide, zinc, selenium, and glutamine |
| enteral whey protein and IV saline | Placebo comparator | Other: saline, Other: sterile water, Other: selenium, Dietary Supplement: whey-proteinsaline, sterile water, whey protein |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- During the initial accrual period for this study, prior to the first interim analysis, patients will be eligible for enrollment if they:
- are between 12 months and less than 18 years; AND
- are within the first 48 hours of the PICU admission; AND
- have an endotracheal tube, central venous catheter (new or old, tunneled or not tunneled), or Foley catheter; AND
- are anticipated to have an indwelling arterial or central venous catheter for blood sampling during the first three days of study enrollment.
Key exclusion criteria (18 listed)
- During the initial accrual period for this study, prior to the first interim analysis, patients will be ineligible for enrollment if ANY of the following is true or anticipated:
- are less than 1 year age; OR
- are greater than or equal to 18 years of age; OR
- have a known allergy to metoclopramide; OR
- planned removal of endotracheal tube, central venous catheter, AND Foley catheters, within 72 hours of study enrollment, OR
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 |
|---|---|---|
| MetoclopramideAlso: Reglan0.2 mg/kg/dose IV every 12 hours | Drug | zinc selenium glutamine metoclopramide |
| Zincone enteral dose daily of zinc chloride (10 mg/day elemental zinc for infants < or equal to one year of age, and 20 mg/day elemental zinc for patients > 1 year of age) | Drug | zinc selenium glutamine metoclopramide |
| Glutamineone enteral dose daily of glutamine 0.3 gm/kg/day | Dietary supplement | zinc selenium glutamine metoclopramide |
| Seleniumone enteral dose daily of selenium (40 μg for infants < 8 months of age, 60 μg for infants 8 to 12 months of age, 90 μg for children 1-3 years, 150 μg for children 4-8 years, 280 μg for children 9 to 13 years, and 400 μg for children > 13 years) | Drug | zinc selenium glutamine metoclopramide |
| salineequivalent volume of intravenous saline | Other | enteral whey protein and IV saline |
| sterile waterequivalent volume of sterile water | Other | enteral whey protein and IV saline |
| seleniumequivalent volume of sterile water | Other | enteral whey protein and IV saline |
| whey-proteinAlso: Beneproteinone enteral dose daily of whey-protein | Dietary supplement | enteral whey protein and IV saline |
Primary outcome
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
4 secondary outcomes
Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days
Time frame: 48 hours after PICU admission till discharge from PICU
Antibiotic-free Days
Time frame: 48 hours after admission until PICU discharge
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
All-cause 28-day Mortality Rate.
Time frame: 28 days after admission to the PICU
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12433670Watson RS, Carcillo JA, Linde-Zwirble WT, Clermont G, Lidicker J, Angus DC. The epidemiology of severe sepsis in children in the United States. Am J Respir Crit Care Med. 2003 Mar 1;167(5):695-701. doi: 10.1164/rccm.200207-682OC. Epub 2002 Nov 14.
- Background: PubMed 3812407Brown RB, Stechenberg B, Sands M, Hosmer D, Ryczak M. Infections in a pediatric intensive care unit. Am J Dis Child. 1987 Mar;141(3):267-70. doi: 10.1001/archpedi.1987.04460030045021.
- Background: PubMed 7984384Stein F, Trevino R. Nosocomial infections in the pediatric intensive care unit. Pediatr Clin North Am. 1994 Dec;41(6):1245-57. doi: 10.1016/s0031-3955(16)38871-x.
- Background: PubMed 2685101Ford-Jones EL, Mindorff CM, Pollock E, Milner R, Bohn D, Edmonds J, Barker G, Gold R. Evaluation of a new method of detection of nosocomial infection in the pediatric intensive care unit: the Infection Control Sentinel Sheet System. Infect Control Hosp Epidemiol. 1989 Nov;10(11):515-20. doi: 10.1086/645938.
- Background: PubMed 3277780Milliken J, Tait GA, Ford-Jones EL, Mindorff CM, Gold R, Mullins G. Nosocomial infections in a pediatric intensive care unit. Crit Care Med. 1988 Mar;16(3):233-7. doi: 10.1097/00003246-198803000-00005.
- Background: PubMed 2194407Allen U, Ford-Jones EL. Nosocomial infections in the pediatric patient: an update. Am J Infect Control. 1990 Jun;18(3):176-93. doi: 10.1016/0196-6553(90)90183-s.
- Background: PubMed 3510104Donowitz LG. High risk of nosocomial infection in the pediatric critical care patient. Crit Care Med. 1986 Jan;14(1):26-8. doi: 10.1097/00003246-198601000-00006.
- Background: PubMed 142452Meakins JL, Pietsch JB, Bubenick O, Kelly R, Rode H, Gordon J, MacLean LD. Delayed hypersensitivity: indicator of acquired failure of host defenses in sepsis and trauma. Ann Surg. 1977 Sep;186(3):241-50. doi: 10.1097/00000658-197709000-00002.
- Background: PubMed 10644489Pellegrini JD, De AK, Kodys K, Puyana JC, Furse RK, Miller-Graziano C. Relationships between T lymphocyte apoptosis and anergy following trauma. J Surg Res. 2000 Feb;88(2):200-6. doi: 10.1006/jsre.1999.5797.
- Background: PubMed 7574928O'Sullivan ST, Lederer JA, Horgan AF, Chin DH, Mannick JA, Rodrick ML. Major injury leads to predominance of the T helper-2 lymphocyte phenotype and diminished interleukin-12 production associated with decreased resistance to infection. Ann Surg. 1995 Oct;222(4):482-90; discussion 490-2. doi: 10.1097/00000658-199522240-00006.
- Background: PubMed 10321662Menges T, Engel J, Welters I, Wagner RM, Little S, Ruwoldt R, Wollbrueck M, Hempelmann G. Changes in blood lymphocyte populations after multiple trauma: association with posttraumatic complications. Crit Care Med. 1999 Apr;27(4):733-40. doi: 10.1097/00003246-199904000-00026.
- Background: PubMed 10608764Gogos CA, Drosou E, Bassaris HP, Skoutelis A. Pro- versus anti-inflammatory cytokine profile in patients with severe sepsis: a marker for prognosis and future therapeutic options. J Infect Dis. 2000 Jan;181(1):176-80. doi: 10.1086/315214.
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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.
Joseph Carcillo, MD principal investigator
University of Pittsburgh Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metoclopramide, Zinc and Glutamine in people with Sepsis, run by Michael Dean at 7 sites in United States.
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 10 inclusion and 18 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: stopped early, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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). 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 NCT00395161, which also lists 74 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 18 Apr 2013.