NCT05946122

Brief Summary

Offering renal protection in systemic inflammatory response syndrome by atorvastatin

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

July 14, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

June 27, 2023

Last Update Submit

July 6, 2023

Conditions

Renal Protection

Outcome Measures

Primary Outcomes (1)

  • Acute kidney injury

    incidence or acute kidney injury

    one week

Secondary Outcomes (3)

  • renal resistive vascular index

    one week

  • APACHE score ( acute physiology and chronic health evaluation)

    one week

  • length of ICU stay

    two weeks

Study Arms (2)

control group

PLACEBO COMPARATOR
Drug: placebo drug

Active ( Ator) group

ACTIVE COMPARATOR
Drug: Atorvastatin 40 Mg Oral Tablet

Interventions

Atorvastatin 40 Mg Oral TabletDRUG

oral atorvastatin for renal protection

Active ( Ator) group
placebo drugDRUG

tablet resembles atorvastatin

control group

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mina Maher Raouf

Minya, Minia University, 6115, Egypt

RECRUITING

MeSH Terms

Interventions

AtorvastatinTablets

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and pain medicine

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 14, 2023

Study Start

May 30, 2023

Primary Completion

December 12, 2023

Study Completion

December 30, 2023

Last Updated

July 14, 2023

Record last verified: 2023-07

Locations

EG(1)