Last Verified: | June/30/2020 |
First Submitted: | July/5/2020 |
Estimated Enrollment Submitted: | July/8/2020 |
First Posted: | July/9/2020 |
Last Update Submitted: | July/21/2020 |
Last Update Posted: | July/22/2020 |
Actual Study Start Date: | July/14/2020 |
Estimated Primary Completion Date: | November/30/2020 |
Estimated Study Completion Date: | December/31/2020 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | Double (Participant, Outcomes Assessor) |
Arm | Intervention/treatment |
---|---|
Placebo Comparator: control group received the standard ALP treatment according to TUPTC protocol as follows: patient resuscitation, care of airway, breathing and circulation, gastric decontamination with 2 ampoules sodium bicarbonate (each ampoule 25 ml containing 2.1 gm sodium bicarbonate) followed by activated charcoal in dose of 1 g/Kg orally, adequate hydration, normal saline administration (0.9% Sodium Chloride IV), vasopressors IV infusions, inhalation of 100% oxygen, ranitidine IV, magnesium sulfate IV infusion and other supportive treatment. | |
Experimental: Hydroxyethyl starch group): Patients will start therapy with Hydroxyethyl starch instead of normal saline (6% hetastarch 600/0.75 in 0.9% sodium chloride) with a dose of 500 cc in 6 hours. Additionally, patient will receive the standard ALP treatment according to TUPTC protocol in the same order of placebo. | |
Experimental: Combined Hydroxyethyl starch and hydrocortisone group Patients will start therapy with combined Hydroxyethyl starch (Voluven®, fresenius kabi, Germany) and hydrocortisone (SOLU-CORTEF 100 mg ampoule) instead of normal saline of normal saline as follow: Hydroxyethyl starch dose is 6% hetastarch 600/0.75 in 0.9% sodium chloride with a dose of 500 cc in 6 hours. Hydrocortisone dose is 200-300 mg /day intravenously until normalization of blood pressure. Additionally, patient will receive the standard ALP treatment according to TUPTC protocol in the same order of placebo. | Drug: Combined Hydroxyethyl starch and hydrocortisone group Hydrocortisone dose is 200-300 mg /day intravenously |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Criteria: | Inclusion Criteria: - Patients with severe acute aluminum phosphide poisoning - systolic blood pressure (SBP) ≤90 mmHg - PH ≤ 7.2 - HCO3 ≤15 meq/L - during the first six hours of admission Exclusion Criteria: - Pregnant and lactating women - Asymptomatic patients with history of acute aluminum phosphide exposure. - Patients with co-ingestion to other substances in addition to aluminum phosphide. - Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure). - Patients with previous medical intervention (fluid therapy and vasopressors). |