Drug Toxicity Clinical Trial
Official title:
Antidote for Valproic Acid Toxicity: a New Indication for Meropenem Antibiotic. A Randomized Placebo-controlled Trial
Acute Valproic acid (VPA) toxicity is an emergency condition which may commonly present with central nervous system (CNS) depression(5). In mild poisoning, associated with VPA ingestions of 200 mg/kg, sedation and lethargy commonly occur(6); while in severe VPA poisoning associated with ingestions of 400 mg/kg or more, life threatening events are likely to occur as respiratory depression, metabolic acidosis, encephalopathy, hemodynamic instability, and cerebral edema which may progress to coma and even death -if not treated promptly. Supportive care along with early gastric decontamination using activated charcoal (AC) (which may only be given if patient presented early after ingestion), in addition to intravenous (IV) administration of Levocarnitine (L-Carnitine) and ensuring adequate airway protection are the cornerstone of treatment, but there remains no drug listed as a specific antidote for acute VPA intoxication. Carbapenem antibiotics augment the clearance of VPA through suppressing its enterohepatic recirculation, as they inhibit the acylpeptide hydrolase enzyme responsible for the reabsorption of the hydrolyzed valproate back to VPA active molecule. Taking advantage of this well-established drug-drug interaction between VPA and carbapenems resulting in significant drop of VPA serum concentration during concomitant use, we propose that administration of meropenem (member of carbapenems group) will prove effectiveness in managing VPA toxicity by achieving lower plasma levels of VPA and/or enhanced alertness; compared with standard care.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | December 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with VPA toxicity will be included if aged 18 years or more. The patient himself/herself should provide informed consent; a family member may take place only if there is an altered mentation that may hinder such procedure. Exclusion Criteria: - Patients will be excluded if presenting one hour following VPA ingestion and were administered AC for gastric decontamination, as it may decrease VPA bioavailability. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria University hospitals | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Mabaret Al-Asafara Hospitals |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate serum Valproic acid concentrations among the two study groups. | Plasma level of valproic acid | 1 year | |
Secondary | Assess patients level of consciousness according to the Glasgow Coma Scale (GCS) among the placebo and treatment groups. Assess patients level of consciousness according to the Glasgow Coma Scale (GCS) among the placebo and treatment groups. | Glasgow coma scale ranging from 3 (not responsive) to 15 (responsive) | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03265613 -
Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis
|
Phase 1/Phase 2 | |
Recruiting |
NCT04696081 -
Atrial Fibrillation in Active Cancer Patients
|
||
Active, not recruiting |
NCT03651778 -
GHB Poisoning and Poisoning Induced by Others
|
||
Completed |
NCT04120233 -
MW151-101: First-in-human Study of MW151
|
Phase 1 | |
Recruiting |
NCT01965275 -
High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs
|
Phase 2 | |
Completed |
NCT01614080 -
Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA
|
N/A | |
Recruiting |
NCT04659343 -
TDM for Optimized Outcome in Patients With mRCC.
|
||
Completed |
NCT02864030 -
PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment
|
Phase 4 | |
Completed |
NCT01135680 -
Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100
|
Phase 1 | |
Completed |
NCT03947034 -
Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
|
||
Recruiting |
NCT03885388 -
Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma (GTN) Patients With Score of 5-6
|
Phase 2/Phase 3 | |
Completed |
NCT00491595 -
Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women
|
Phase 1 | |
Recruiting |
NCT03469063 -
Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients
|
N/A | |
Completed |
NCT03280368 -
Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation
|
||
Withdrawn |
NCT01374061 -
Pre Hospital Evaluation of Video Laryngoscopy
|
Phase 4 | |
Completed |
NCT03994302 -
Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)
|
||
Completed |
NCT03392311 -
Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis
|
Phase 1/Phase 2 | |
Terminated |
NCT00090844 -
Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer
|
Phase 2 | |
Terminated |
NCT00213642 -
Tc-99m Renography and Cisplatin-induced Nephrotoxicity
|
N/A | |
Terminated |
NCT05022797 -
Reduction of MTX Levels After Glucarpidase Treatment in DLBCL Patients at Risk of CNS
|
Phase 2 |