NCT05370729

Brief Summary

Assess impact of ILE and NAC in morbidity and mortality when used as adjuvant therapy to routine management of acute ALP poisoning.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

May 11, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

March 21, 2022

Last Update Submit

May 8, 2022

Conditions

Myocardial Injury

Keywords

Aluminum phosphide poisoningsIntralipid emulsionN-acetylcystieneMyocardial injuryEchocardiography

Outcome Measures

Primary Outcomes (1)

  • Echocardiography

    Follow up cardiac function by echocardiography focusing on LV EF

    24 hours

Secondary Outcomes (2)

  • Renal function test

    24 hours

  • Total days of ICU stay

    Up to two weeks

Study Arms (2)

N-acetyl cysteine (NAC)

EXPERIMENTAL

Conservative management + ILE infusion 10 ml/hr + N-acetyl cysteine (NAC) infusion 150 mg/kg body weight in 200 ml of 5% dextrose over 1 h, followed by 50 mg/kg body weight in 500 ml of 5% dextrose over 4 h, and then 100 mg/kg body weight in 1000 ml of 5% dextrose over 16 h.

Drug: N-acetyl cysteine

Intra lipid emulsion (ILE)

NO INTERVENTION

Conservative management + ILE infusion 10 ml/hr + normal saline infusion

Interventions

N-acetyl cysteineDRUG

Intravenous infusion of NAC 150 mg/kg body weight in 200 ml of 5% dextrose over 1 h, followed by 50 mg/kg body weight in 500 ml of 5% dextrose over 4 h, and then 100 mg/kg body weight in 1000 ml of 5% dextrose over 16 h.

Also known as: NAC
N-acetyl cysteine (NAC)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presentation with symptomatic acute ALP poisoning.
  • History of exposure including reliable identification of the compound based on the container brought by patient's relatives.
  • The suggestive clinical manifestations following shortly after a single exposure to ALP.

You may not qualify if:

  • Co-ingestion or exposure to other substances in addition to ALP.
  • Patients had major medical conditions (e.g., cardiovascular disease, renal or hepatic failure).
  • Patients received treatment in any hospital or medical center before admission - other than emergency department of Assiut University Hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Baruah U, Sahni A, Sachdeva HC. Successful management of aluminium phosphide poisoning using intravenous lipid emulsion: Report of two cases. Indian J Crit Care Med. 2015 Dec;19(12):735-8. doi: 10.4103/0972-5229.171412.

    PMID: 26816450BACKGROUND

  • Tehrani H, Halvaie Z, Shadnia S, Soltaninejad K, Abdollahi M. Protective effects of N-acetylcysteine on aluminum phosphide-induced oxidative stress in acute human poisoning. Clin Toxicol (Phila). 2013 Jan;51(1):23-8. doi: 10.3109/15563650.2012.743029. Epub 2012 Nov 14.

    PMID: 23148565BACKGROUND

  • Agarwal A, Robo R, Jain N, Gutch M, Consil S, Kumar S. Oxidative stress determined through the levels of antioxidant enzymes and the effect of N-acetylcysteine in aluminum phosphide poisoning. Indian J Crit Care Med. 2014 Oct;18(10):666-71. doi: 10.4103/0972-5229.142176.

    PMID: 25316977BACKGROUND

  • Tsutamoto T, Wada A, Maeda K, Hisanaga T, Maeda Y, Fukai D, Ohnishi M, Sugimoto Y, Kinoshita M. Attenuation of compensation of endogenous cardiac natriuretic peptide system in chronic heart failure: prognostic role of plasma brain natriuretic peptide concentration in patients with chronic symptomatic left ventricular dysfunction. Circulation. 1997 Jul 15;96(2):509-16. doi: 10.1161/01.cir.96.2.509.

    PMID: 9244219BACKGROUND

MeSH Terms

Interventions

Acetylcysteine

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Ola M Wahba, PHD, MD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Tassbeeh Kamal

CONTACT

01065656202tk.zanaty_92@med.aun.edu.eg

Shimaa A Hassan, PHD, MD

CONTACT

01002953253shimaa.abbas@med.aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 21, 2022

First Posted

May 11, 2022

Study Start

May 1, 2022

Primary Completion

May 1, 2024

Study Completion

May 1, 2025

Last Updated

May 11, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share