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

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ClinicalTrials.gov Identifier: NCT05946122
Recruitment Status : Recruiting
First Posted : July 14, 2023
Last Update Posted : July 14, 2023
Sponsor:
Information provided by (Responsible Party):
Mina Maher, Minia University

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

Condition or disease Intervention/treatment Phase
Renal Protection Drug: Atorvastatin 40 Mg Oral Tablet Drug: placebo drug Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Atorvastatin as a Renal Protection in Patients With Systemic Inflammatory Response Syndrome Using Renal Arterial Resistive Index
Actual Study Start Date : May 30, 2023
Estimated Primary Completion Date : December 12, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Acute kidney injury [ Time Frame: one week ]
    incidence or acute kidney injury


Secondary Outcome Measures :
  1. renal resistive vascular index [ Time Frame: one week ]
    renal resistive index

  2. 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 .

  3. length of ICU stay [ Time Frame: two weeks ]
    days of ICU admission


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05946122


Locations
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Egypt
Mina Maher Raouf Recruiting
Minia, Minia University, Egypt, 6115
Contact: mina M raouf, MBBCH    02-01015752424    marlin27zarif@gmail.com   
Sponsors and Collaborators
Minia University
More Information
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Responsible Party: Mina Maher, lecturer of anesthesia and pain medicine, Minia University
ClinicalTrials.gov Identifier: NCT05946122    
Other Study ID Numbers: 343/ 8-2022
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: July 14, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Atorvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors