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
About this trial
This is an interventional prevention trial for Renal Protection
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.
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
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
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