Rapid Administration of Carnitine in sEpsis (RACE)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Prior work has shown that exogenous L-carnitine administration enhances glucose and lactate oxidation, attenuates fatty acid toxicity, and improves endothelial-smooth muscle coupling and cardiac mechanical efficiency. The overall goal of this proposal is to investigate L-carnitine as a novel adjunctive treatment of septic shock. In this study the investigators will test our primary hypothesis: Early adjunctive L-carnitine administration in vasopressor dependent septic shock will significantly reduce cumulative organ failure at 48 hours with an associated decrease in 28-day mortality suggesting the need for further phase III study. To accomplish this the investigators will conduct a phase II, double blinded, placebo controlled, adaptive randomized trial of 250 eligible patients with vasopressor-dependent septic shock. Study subjects will be assigned to one of four arms: low (6g), medium (12g) or high (18g) dose intravenous L-carnitine or placebo for 12 hours as a part of early resuscitative care.
| Condition | Intervention | Phase |
|---|---|---|
|
Septic Shock |
Drug: Levo-Carnitine Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of Levo-Carnitine for Vasopressor Dependent Septic Shock |
- delta SOFA [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 28 day ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Control
Normal saline
|
Drug: placebo |
|
Experimental: Carnitine Low
Levo-Carnitine 6g
|
Drug: Levo-Carnitine |
|
Experimental: Carnitine Medium
Levo-Carnitine 12 g
|
Drug: Levo-Carnitine |
|
Experimental: Carnitine High
Levo-Carnitine 18 g
|
Drug: Levo-Carnitine |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Suspected or confirmed infection (examples include but are not limited to: white cells in a normally sterile body fluid; perforated viscus; radiographic evidence of pneumonia in clinical symptoms; a syndrome associated with a high risk of infection e.g. cellulitis, cutaneous abscess, ascending cholangitis, toxic shock syndrome, fever of unknown origin with high suspicion of infectious etiology)
- Any two of four criteria of systemic inflammatory response as defined by the 2001 ACCP/SCCM Consensus Conference Committee;
- Recognition of septic shock and initiation of quantitative resuscitation within 24 hours of enrollment;
- Requirement of high dose vasopressors for ≥4 hours to treat shock: Norepinephrine > 0.05mcg/kg/min; dopamine >10mcg/kg/min; Phenylephrine >0.4 mcg/kg/min; epinephrine > 0.05 mcg/kg/min;
- Cumulative sequential organ failure assessment (SOFA) score of ≥ 6;
- Blood lactate level of >2.0 mMol/L.
Exclusion Criteria:
- Age <18 years;
- Pregnancy or breastfeeding;
- Any primary diagnosis other than sepsis;
- Established Do Not Resuscitate status or advanced directives restricting aggressive care or treating physician deems aggressive care unsuitable;
- Any history of seizures or a known seizure disorder;
- Any known inborn error of metabolism;
- Anticipated requirement for surgery that would interfere with the 12 hour infusion time;
- Active participation in another interventional study;
- Cardiopulmonary resuscitation (chest compression or defibrillation) prior to enrollment;
- Known systemic allergy to L-carnitine.
- Severe immunocompromised state (e.g. subject has neutropenia [receiving cytotoxic chemotherapy with absolute neutrophil count <500/uL or expected to decline to < 500 uL within the next three days).
Contacts and Locations| Contact: Alan Jones, MD | 601-984-5443 | aejones@umc.edu |
| United States, Illinois | |
| Northwestern University | Not yet recruiting |
| Chicago, Illinois, United States | |
| Contact: Mark Courtney, MD | |
| Principal Investigator: Mark Courtney, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States | |
| Contact: Jeffrey Kline, MD | |
| Principal Investigator: Jeffrey Kline, MD | |
| United States, Massachusetts | |
| BIDMC | Recruiting |
| Boston, Massachusetts, United States | |
| Contact: Nathan Shapiro, MD | |
| Principal Investigator: Nathan Shapiro, MD | |
| United States, Michigan | |
| Univeristy of Michigan | Not yet recruiting |
| Ann Arbor, Michigan, United States | |
| Contact: John Younger, MD | |
| Principal Investigator: John Younger, MD | |
| United States, Mississippi | |
| University of Mississippi Medical Center | Recruiting |
| Jackson, Mississippi, United States, 29316 | |
| Contact: Alan Jones, MD 601-984-5443 aejones@umc.edu | |
| Principal Investigator: Alan Jones, MD | |
| United States, New Jersey | |
| Cooper University Hospital | Not yet recruiting |
| Camden, New Jersey, United States | |
| Contact: Stephen Trzeciak, MD | |
| Principal Investigator: Stephen Trzeciak, MD | |
| United States, North Carolina | |
| Carolinas Medical Center | Recruiting |
| Charlotte, North Carolina, United States | |
| Contact: Mike Runyon, MD | |
| Principal Investigator: Mike Runyon, MD | |
| Principal Investigator: | Alan Jones, MD | University of Mississippi Medical Center |
More Information
No publications provided
| Responsible Party: | Alan Jones, Professor of Emergency Medicine, University of Mississippi Medical Center |
| ClinicalTrials.gov Identifier: | NCT01665092 History of Changes |
| Other Study ID Numbers: | GM103799 |
| Study First Received: | August 11, 2012 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Shock Shock, Septic Pathologic Processes Sepsis Infection Systemic Inflammatory Response Syndrome Inflammation |
Carnitine Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013