Potential Therapeutic RoleNCT04465539
The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning
A study testing Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven] and Hydrocortisone in people with Potential Therapeutic Role, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Potential Therapeutic Role
- What is being tested?
- Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven] and Hydrocortisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2020to 30 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning: A Randamized Controlled Clinical Trial
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
Read the 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.
- Conditions
- Potential Therapeutic Role
- Being tested
- Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven], Hydrocortisone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]Drug
Hydroxyethyl starch dose is 500 cc in 6 hours
HydrocortisoneDrug
Hydrocortisone dose is 200-300 mg /day intravenously
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | 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. Receives: Drug: Placebo |
| Hydroxyethyl starch group): | Experimental | 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. Receives: Drug: Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]; Drug: Placebo |
| Combined Hydroxyethyl starch and hydrocortisone group | Experimental | 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. Receives: Drug: Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]; Drug: Hydrocortisone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality rate of patients
Measured: 28 days from start of management
Secondary outcomes (2)
Need for mechanical ventilation
incidence of need for intubation and mechanical ventilation for each patient
Measured: Through study completion up to 6 months
need for ICU admission
the incidence of need for ICU admission for each patient
Measured: Through study completion up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start15 Jul 2020
- Primary completion28 Feb 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potential Therapeutic RoleStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tarek abdel hay mostafa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465539
- Sponsor's protocol ID
- HES & hydrocortisone
- Status last verified
- Apr 2024
- First submitted
- 6 Jul 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning: A Randamized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04465539
- Acronym / sponsor ID
- HES & hydrocortisone
- Conditions
- Potential Therapeutic Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 10 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Placeboreceived 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. |
| Hydroxyethyl starch group): | Experimental | Drug: Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven], Drug: PlaceboPatients 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. |
| Combined Hydroxyethyl starch and hydrocortisone group | Experimental | Drug: Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven], Drug: Hydrocortisone, Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]Hydroxyethyl starch dose is 500 cc in 6 hours | Drug | Combined Hydroxyethyl starch and hydrocortisone group, Hydroxyethyl starch group): |
| HydrocortisoneHydrocortisone dose is 200-300 mg /day intravenously | Drug | Combined Hydroxyethyl starch and hydrocortisone group |
| Placeboreceived 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. | Drug | Combined Hydroxyethyl starch and hydrocortisone group, Hydroxyethyl starch group):, control group |
Primary outcome
mortality
Time frame: 28 days from start of management
mortality rate of patients
2 secondary outcomes
Need for mechanical ventilation
Time frame: Through study completion up to 6 months
need for ICU admission
Time frame: Through study completion up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven] and Hydrocortisone in people with Potential Therapeutic Role, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 28 days from start of management). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.