Effect of Statin Therapy on Mortality in Patients With Ventilator Associated Pneumonia

NCT05230472 | Completed Phase 4 DMC

• 1 other identifier: EMASU M D 219 /2020
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

Statins with their powerful anti-inflammatory, immunomodulatory, and antioxidant properties make them candidate members to be used in the management of sepsis and different types of infections including pneumonia. This study aims to determine whether adjunctive statin therapy decreased day- 28 mortality among ICU patients with ventilator-associated pneumonia (VAP) \& number of ventilator-free days (after successful weaning) between day 1 and both day 28.

Conditions

VAP - Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• The primary outcome was the day-28 mortality rate.

  asses effect of statin on mortality in ventilator associated pneumonia patient

  28 day

Secondary Outcomes (3)

• ICU mortality rates

  between day 1 and day 28

• number of days outside the ICU between day 1 and day 28

  between day 1 and day 28

• number of ventilator-free days (after successful weaning) between day 1 and both day 28.

  between day 1 and day 28

Study Arms (2)

simvastatin group

ACTIVE COMPARATOR

68 patients who had a ventilator associated pneumonia received simvastatin

Drug: Simvastatin

control group

NO INTERVENTION

68 patients who had a ventilator associated pneumonia not received simvastatin

Interventions

Simvastatin DRUG

simvastatin 60 mg tab

simvastatin group

Eligibility Criteria

• Age: 29 Years - 71 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who suspected to had VAP defined as a modified Clinical Pulmonary Infection Score (CPIS) of at least 5 and if they underwent quantitative bacteriological cultures of bronchoalveolar lavage (BAL) fluid, a protected telescopic catheter (PTC), or an endotracheal aspirate. The modified CPIS is based on body temperature, blood leukocyte count, amount and appearance of tracheal secretions, ratio of partial pressure of oxygen (PaO2) to fraction of inspired oxygen, acute respiratory distress syndrome (ARDS), and infiltrates on chest radiography. The total can range from 1 to 10 points (Luna et al., 2003).
• Patients were included only for the first episode of suspected VAP.

You may not qualify if:

• o Statin therapy at intubation
• Previous VAP episode during the same hospitalization
• Known pregnancy
• Immunodepression with bone marrow aplasia
• Imminent death (Simplified Acute Physiology Score II of 75 or greater, calculated over the last 6 hours)
• Treatment limitation decisions
• Nothing-by-mouth order and no nasogastric tube, continuous gastric aspiration
• Known chronic intestinal malabsorption
• Known simvastatin hypersensitivity
• Acute hepatic failure
• Use of CYP3A4 inhibitors or cyclosporine
• Creatine kinase level greater than 5 times the upper limit of normal
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than 3 times the upper limit of normal

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11311, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• YOUSEF FAWZY

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Block size was unknown to the investigators, who was enrolled the patients and then called the statistics department to obtain the randomization and treatment numbers after checking the inclusion and non-inclusion criteria.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: hananfarag@med.asu.edu.eg

Model Details: Patients were randomly allocated to simvastatin (60 mg) or control given via a nasogastric tube or orally from study inclusion to ICU discharge, death, or day 28, whichever occurred first. Simvastatin or control were started on the same day as antibiotic therapy for suspected VAP. The simvastatin dosage was halved in patients with renal failure (creatinine clearance \<30 mL/min). A computer-generated random- number table was prepared by statisticians to assign patients in blocks of 4 to receive either simvastatin or control. Block size was unknown to the investigators, who was enrolled the patients and then called the statistics department to obtain the randomization and treatment numbers after checking the inclusion and non-inclusion criteria.

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 9, 2022
• Study Start: January 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: February 1, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)