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

• Sponsor: Minia University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05946122
• Collaborator: (none)
• Enrollment: 106
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7
• Patients Per Site Per Month: 15.1

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Primary Completion Date: Dec 12, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Acute kidney injury [one week]

   incidence or acute kidney injury

Secondary Outcome Measures

1. renal resistive vascular index [one week]

   renal resistive index

2. APACHE score ( acute physiology and chronic health evaluation) [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 [two weeks]

   days of ICU admission

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Mina Maher Raouf	Minia	Minia University	Egypt	6115

Sponsors and Collaborators

• Minia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Jul 14, 2023
• Last Update Posted: Jul 14, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Systemic Inflammatory Response Syndrome; Atorvastatin

Study Results

No Results Posted as of Jul 14, 2023