search
Back to results

The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning

Primary Purpose

Potential Therapeutic Role

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]
Hydrocortisone
Placebo
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Potential Therapeutic Role

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Tarek Abdel HayRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

control group

Hydroxyethyl starch group):

Combined Hydroxyethyl starch and hydrocortisone group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

mortality
mortality rate of patients

Secondary Outcome Measures

Need for mechanical ventilation
incidence of need for intubation and mechanical ventilation for each patient
need for ICU admission
the incidence of need for ICU admission for each patient

Full Information

First Posted
July 6, 2020
Last Updated
July 22, 2020
Sponsor
Tanta University
search

1. Study Identification

Unique Protocol Identification Number
NCT04465539
Brief Title
The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning
Official Title
The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning: A Randamized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aluminum phosphide (ALP) is a widely used fumigant due to its efficiency as pesticides. It is available as tablets of Celphos, Alphos or Quickphos which are known as rice tablets. Each tablet weights 3 grams and contains 56% ALP and 44% of aluminum carbonate and paraffin. The incidence of ALP poisoning increased steadily specially in developing countries . ALP poisoning is considered to be one of the major causes of suicidal poisoning owing to its wide accessibility and low cost. However, accidental poisoning may occur during occupational exposure
Detailed Description
Aluminum phosphide (ALP) is a widely used fumigant due to its efficiency as pesticides. It is available as tablets of Celphos, Alphos or Quickphos which are known as rice tablets. Each tablet weights 3 grams and contains 56% ALP and 44% of aluminum carbonate and paraffin. The incidence of ALP poisoning increased steadily specially in developing countries . ALP poisoning is considered to be one of the major causes of suicidal poisoning owing to its wide accessibility and low cost. However, accidental poisoning may occur during occupational exposure. Signs and symptoms of acute AlP poisoning include gastrointestinal, cardiovascular, hepatic, renal, and neurologic (1). Ingestion of ALP causes mild gastrointestinal (GIT) manifestations as nausea, vomiting, abdominal pain, in addition to chest tightness, hypotension, headache and dizziness. In severe cases, GIT hemorrhage, shock, severe metabolic acidosis, cardiac arrhythmia, convulsions and coma may occur. Later, signs of hepatic damage and renal insufficiency may develop. Death usually occurs in 30-70% of cases within the first 24 hours resulting from refractory cardiogenic shock, cardiac arrhythmia, severe hypotension and metabolic acidosis.The main causes of cardiovascular collapse are increase capillary permeability, insufficient systemic vasoconstriction with low ventricular ejection fraction. On autopsy examinations, point to extravasation of fluid into the third space. The management is exclusively supportive as gastric lavage with KMnO4 solution, treatment of hypotension and acidosis in view of the fact that there is no specific antidote available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Potential Therapeutic Role

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Hydroxyethyl starch group):
Arm Type
Experimental
Arm Description
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.
Arm Title
Combined Hydroxyethyl starch and hydrocortisone group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]
Intervention Description
Hydroxyethyl starch dose is 500 cc in 6 hours
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Intervention Description
Hydrocortisone dose is 200-300 mg /day intravenously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
mortality
Description
mortality rate of patients
Time Frame
28 days from start of management
Secondary Outcome Measure Information:
Title
Need for mechanical ventilation
Description
incidence of need for intubation and mechanical ventilation for each patient
Time Frame
Through study completion up to 6 months
Title
need for ICU admission
Description
the incidence of need for ICU admission for each patient
Time Frame
Through study completion up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Tarek Abdel Hay
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tarek abdelhay mostafa, MD
Phone
0201003591332
Email
dr.tarek311@yahoo.com

12. IPD Sharing Statement

Learn more about this trial

The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning

We'll reach out to this number within 24 hrs