NCT04815512

Brief Summary

The aim of this study is to assess the liver and renal functions of individuals who are occupationally exposed to petroleum products.

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
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

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 15, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 15, 2021

Last Update Submit

March 22, 2021

Conditions

Petroleum Product Toxicity

Outcome Measures

Primary Outcomes (4)

  • measurement of serum alanine amino transferase (ALT) in study participants.

    Number of participants with abnormal findings in serum alanine amino transferase (ALT) will be reported.

    6 months

  • measurement of serum aspartate amino transferase (AST) in study participants.

    Number of participants with abnormal findings in serum aspartate amino transferase (AST) will be reported.

    6 months

  • measurement of serum total bilirubin in study participants.

    Number of participants with abnormal findings in serum total bilirubin will be reported.

    6 months

  • measurement of serum albumin (ALB) in study participants.

    Number of participants with abnormal findings in serum albumin (ALB) will be reported.

    6 months

Secondary Outcomes (2)

  • Measurement of serum urea in study participants.

    6 months

  • Measurement of serum Creatinine in study participants.

    6 months

Study Arms (2)

exposed group

workers in The Petroleum Pipelines Company who are occupationally exposed to petroleum products will be included in the study.

Diagnostic Test: Liver function tests.Diagnostic Test: kidney function tests

Comparison group (control group)

healthy administrative workers in assiut university

Diagnostic Test: Liver function tests.Diagnostic Test: kidney function tests

Interventions

Liver function tests.DIAGNOSTIC_TEST

serum alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (ALB), alkaline Phosphatase (ALP), total bilirubin.

Comparison group (control group)exposed group
kidney function testsDIAGNOSTIC_TEST

creatinine , urea and serum uric acid will be analysed in the serum.

Comparison group (control group)exposed group

Eligibility Criteria

Age20 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

workers who are occupationally exposed to petroleum products in The Petroleum Pipelines Company in assiut.The Petroleum Pipelines Company is responsible for transporting and storing crude oil and its products and has a large network of lines.

You may qualify if:

  • for exposed group:
  • Apparently health workers who exposed for petroleum products in The Petroleum Pipelines Company in assiut will be included in the study

You may not qualify if:

  • for exposed and Comparison groups
  • history of hepatic and renal health problem
  • history of taking medications affecting liver and renal function tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Malini SS, Maithily K. Analysis of oxidative stress in chronic exposure to petroleum hydrocarbons in Karnataka,India. Asia Pac J Med Toxicol. 2017; 6(1):6-11.

    BACKGROUND

  • Bin-Mefrij M, Alwakeel S. The effect of fuel inhalation on the kidney and liver function and blood indices in gasoline station workers. Adv Nat Appl Sci. 2017; 11(1):45-50.

    BACKGROUND

  • Olmedo-Buenrostro BA, Ortega-Ortiz JG, Guzman-Esquivel J, Delgado-Enciso OG, Ceja-Espiritu G,Paz-Michel BA, et al. Workplace gasoline exposure increases the risk for early renal dysfunction: A case-control study in Mexico. Biomed Res. 2017; 28 (22): 9859-9863.

    BACKGROUND

  • Asefaw T, Wolde M, Edao A, Tsegaye A, Teklu G, Tesfay F, Gebremariam G. Assessment of liver and renal function tests among gasoline exposed gas station workers in Mekelle city, Tigray region, Northern Ethiopia. PLoS One. 2020 Oct 9;15(10):e0239716. doi: 10.1371/journal.pone.0239716. eCollection 2020.

    PMID: 33035217BACKGROUND

MeSH Terms

Interventions

Liver Function TestsKidney Function Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Urological

Study Officials

  • Hanan M. Ahmed, Prof.

    Assiut University

    STUDY CHAIR

Central Study Contacts

Shimaa A. Mohammed, Lecturer

CONTACT

0201000525137shima_dola@yahoo.com

Marwa K. Abdo, Assist.Prof

CONTACT

0201097878113Marwa.kamal82@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Occuational and Environmental Medicine

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 25, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

March 25, 2021

Record last verified: 2021-03