L-carnitine as an Adjunct Treatment for Septic Shock Patients With Acute Kidney Injury

NCT02664753 | Terminated Phase 3 DMC

• 1 other identifier: PHRC-N/2015/PR-01
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 11

Brief Summary

The primary objective of this study is to compare 28 day mortality rates between septic shock patients with acute renal insufficiency treated via L-Carnitine (as an adjunct therapy) versus a similar group of patients not receiving L-Carnitine adjunct therapy.

Conditions

Severe Sepsis; Shock, Septic; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Mortality

  28 days

Secondary Outcomes (33)

• First secondary objective of this study is to compare 10 day mortality rates of septic shock patients with renal insufficiency treated via L-Carnitine (as an adjunct therapy) for 56 days versus a patients not receiving L-Carnitine adjunct therapy.

  10 days

• Adverse Events per patient

  12 months (throughout study)

• Survival

  12 months (throughout study)

• The number of days alive and not on renal replacement therapy

  12 months

• The number of days alive and free of renal failure

  12 months

Study Arms (2)

L-Carnitine group

EXPERIMENTAL

Patients in the experimental arm will receive 10 days of intravenous L-carnitine treatment followed by 46 days of oral L-Carnitine treatment. Intervention: 56 days of weight-adjusted L-Carnitine treatment

Drug: 56 days of weight-adjusted L-Carnitine treatment

Placebo then open group

PLACEBO COMPARATOR

Patients in the placebo arm will receive 10 days of intravenous isotonic saline in a fashion analogous to the experimental arm (they study is thus blinded for the first 10 days and then open there afterwards). Intervention: 10 days of intravenous placebo (isotonic saline)

Drug: 10 days of intravenous placebo (isotonic saline)

Interventions

56 days of weight-adjusted L-Carnitine treatment DRUG

Patients in the experimental arm will receive 10 days of intravenous L-carnitine treatment followed by 46 days of oral L-Carnitine treatment. Day 1: a first bolus of 6g of L-Carnitine is administered with a syringe driver of 50 ml. Day 2 to Day 10: Two mini-perfusions are prepared each day, corresponding to 1 administration every 12 hours. 50 mg/kg/day (rounded up to the next gram) L-Carnitine is added to each syringes For the next 46 days, patients will take oral doses of L-Carnitine as follows: \< à 60kg : 2g/day \> 60kg : 3g/day If the patient leaves the hospital before D10, oral treatment can be initiated at the end of the hospitalization

L-Carnitine group

10 days of intravenous placebo (isotonic saline) DRUG

Patients in the placebo arm will receive 10 days of intravenous isotonic saline in a fashion analogous to the experimental arm (they study is thus blinded for the first 10 days and then open there afterwards). Day 1: 1 50ml syringe driver of 50 ml isotonic saline solution . Day 2 to Day 10 : Two syringe drivers of 50 ml of isotonic saline solution are prepared each day, one during the morning and one during the evening.

Placebo then open group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be insured or beneficiary of a health insurance plan
• The patient is at least 18 years old
• The patient was admitted to an intensive care unit (participating in the study) for sepsis or septic shock and presented with acute renal failure requiring, at some point, the use of extra-renal purification.
• The patient has sepsis or septic shock according to international criteria SEPSIS 3 (Singer et al, The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) ; JAMA. 2016)
• The patient has acute renal insufficiency with an KDIGO score of 3
• The patient has started continuous renal replacement therapy (CRRT) or intermittent renal replacement therapy (IRRT) within the previous 72 hours, or will start RRT (CRRT or IRRT) within the next 72 hours.

You may not qualify if:

• The patient is participating in, or has participated in over the past three months, another interventional study that may interfere with the results or conclusions of this study
• The patient is under judicial protection, or is an adult under guardianship
• The patient is pregnant, parturient or breastfeeding
• The patient is susceptible to procreate and does not use methods of effective contraception (contraceptive hormonal ring, surgical contraception, contraceptive implant, contraceptive pill, male or female sheaths, skin patch, intrauterine contraceptive device)
• If the patient is unable to sign a consent form: the patient-designated trusted person or family member refuses to sign the consent form
• If the patient is unable to sign a consent form: It is impossible to correctly inform the patient-designated trusted person or family member
• The patient is able/apt to sign a consent form, but refuses to do so
• The patient is able/apt to sign a consent form, but cannot be correctly informed
• Septic shock without associated AKI
• Patients with a known allergy to L-Carnitine or other component of levocarnil oral solution or for injection
• Pre-existing chronic disease requiring dialysis
• The patient has stage 4 CKD with baseline DFG (CDK) if known \<30 ml
• History of seizures or epilepsy
• Chronic bowel disease or history of chronic diarrhoea
• Under treatment with sodium valproate

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (11)

CHU de Caen

Caen, 14033, France

Location

CH de Chartres

Chartres, France

Location

CHU de Clermont Ferrand

Clermont-Ferrand, 63003, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CHU Lyon

Lyon, France

Location

CHU de Montpellier - Lapeyronie

Montpellier, 34295, France

Location

CHU de Montpellier - St Eloi

Montpellier, 34295, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

CHU de Poitiers

Poitiers, 86021, France

Location

CHU de St Etienne

Saint-Priest-en-Jarez, 42270, France

Location

CHU de Toulouse - Hôpital Rangueil

Toulouse, 31059 T, France

Location

Related Publications (1)

• Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G; SCCM/ESICM/ACCP/ATS/SIS. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003 Apr;31(4):1250-6. doi: 10.1097/01.CCM.0000050454.01978.3B.

  PMID: 12682500 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Acute Kidney Injury

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Pascal Reboul, MD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 27, 2016
• Study Start: March 5, 2018
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Locations

FR (11)