Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ALA | Registry Identifier | Alpha Lipoic Acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tanta University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an adjuvant in the management of patients with acute phosphide poisoning.
The study will be carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospital, Tanta University and Emergency Hospital, Mansoura University) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent will be taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data will be maintained by making code numbers for each patient. The investigators plan to conduct a randomized clinical trial to evaluate efficacy and safety of ALA as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients will be randomized to ALA or a non ALA in a 1:1 ratio (25 patients in each group). ALA will be given IV, as a dose of 600 mg/12 hours. Patients will be monitored and a detailed documentation of any adverse effect due to ALA therapy will be recorded.
This intervention represents an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination (with sodium bicarbonate, and activated charcoal [1 g/Kg, orally] in the first 6 hours after onset of poisoning), adequate hydration and supportive treatment. All the patients will be followed up until discharge or death. All patients will be subjected to:
I. History. II. Clinical examination. III. Laboratory investigations: At admission and repeated before discharge.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alpha Lipoic Acid | Active Comparator | Subjects in this arm will receive ALA IV, as a dose of 600 mg/12 hours. |
|
| Non-Alpha Lipoic Acid | Placebo Comparator | Subjects in this arm will to receive standard treatment only (without Alpha Lipoic Acid, instead they will receive placebo , which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination (with sodium bicarbonate, and activated charcoal [1 g/Kg, orally] in the first 6 hours after onset of poisoning), adequate hydration and supportive treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alpha Lipoic Acid (Thioctacid) | Drug | 600 mg/12 hours, IV (in the vein) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death Rate | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospital stay | Duration that patient will stay in hospital | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Need for intubation | will the patient need to be intubated or not | 2 years |
Inclusion Criteria:
Patients (male or female, aged 12 years or older) with symptomatic acute phosphide poisoning (deliberate or accidental), with diagnosis made on the basis of:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo (for Alpha Lipoic Acid) | Drug | Normal saline in syringe simulating Alpha Lipoic Acid 600mg |
|
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |