search
Back to results

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

Primary Purpose

Renal Protection

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Atorvastatin 40 Mg Oral Tablet
placebo drug
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Protection

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mina Maher RaoufRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control group

Active ( Ator) group

Arm Description

Outcomes

Primary Outcome Measures

Acute kidney injury
incidence or acute kidney injury

Secondary Outcome Measures

renal resistive vascular index
renal resistive index
APACHE score ( acute physiology and chronic health evaluation)
acute physiology and chronic health evaluation, values below 40 are considered normal while values between 41 and 71 are considered abnormal .
length of ICU stay
days of ICU admission

Full Information

First Posted
June 27, 2023
Last Updated
July 6, 2023
Sponsor
Minia University
search

1. Study Identification

Unique Protocol Identification Number
NCT05946122
Brief Title
Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index
Official Title
Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
December 12, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Offering renal protection in systemic inflammatory response syndrome by atorvastatin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Protection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Title
Active ( Ator) group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 40 Mg Oral Tablet
Intervention Description
oral atorvastatin for renal protection
Intervention Type
Drug
Intervention Name(s)
placebo drug
Intervention Description
tablet resembles atorvastatin
Primary Outcome Measure Information:
Title
Acute kidney injury
Description
incidence or acute kidney injury
Time Frame
one week
Secondary Outcome Measure Information:
Title
renal resistive vascular index
Description
renal resistive index
Time Frame
one week
Title
APACHE score ( acute physiology and chronic health evaluation)
Description
acute physiology and chronic health evaluation, values below 40 are considered normal while values between 41 and 71 are considered abnormal .
Time Frame
one week
Title
length of ICU stay
Description
days of ICU admission
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Mina Maher Raouf
City
Minia
State/Province
Minia University
ZIP/Postal Code
6115
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mina M raouf, MBBCH
Phone
02-01015752424
Email
marlin27zarif@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs