Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index

July 6, 2023 updated by: Mina Maher, Minia University
Offering renal protection in systemic inflammatory response syndrome by atorvastatin

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Minia University
      • Minia, Minia University, Egypt, 6115
        • Recruiting
        • Mina Maher Raouf
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ( male and female) with systemic inflammatory response ( total leucocytic count >12,000 mm3'. temperature >38 C, Heart rate >90 b/min and respiratory rate>20 cycle).

Exclusion Criteria:

  • Hemodynamic instability
  • Pre-admission chronic kidney disease.
  • Intra-vascular coagulopathy
  • Patients with myopathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
Drug: placebo drug
tablet resembles atorvastatin
Active Comparator: Active ( Ator) group
Drug: Atorvastatin 40 Mg Oral Tablet
oral atorvastatin for renal protection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute kidney injury
Time Frame: one week
incidence or acute kidney injury
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
renal resistive vascular index
Time Frame: one week
renal resistive index
one week
APACHE score ( acute physiology and chronic health evaluation)
Time Frame: one week
acute physiology and chronic health evaluation, values below 40 are considered normal while values between 41 and 71 are considered abnormal .
one week
length of ICU stay
Time Frame: two weeks
days of ICU admission
two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

December 12, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 343/ 8-2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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