Effect of Bronchoscopy on the Outcome of Patients With Severe Sepsis With ARDS and Complicated by VAP From Prolonged Ventilation

NCT04553367 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: ICU-40-20
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

to evaluate the effect of use of bronchoscopy in the course of sepsis, weaning from the ventilator, duration of ICU stays and mortality rate in septic patients with ARDS due to VAP.

Conditions

ARDS; Septic Shock

Outcome Measures

Primary Outcomes (2)

• number of patients weaned from the ventilator

  those who had improvement in all parameters of sepsis (SOFA score) and improvement in (CPIS) score

  2 weeks

• number of patients disharged from ICU

  Those who weaned from the ventilator and recoverd from sepsis

  2 weeks

Study Arms (2)

Group A

PLACEBO COMPARATOR

patients of group A Continue on the conventional way of ventilation and . Microbiological results collected from patients of group A through qualitative sputum.

Drug: Meropenem; Device: ventilator

Group B

ACTIVE COMPARATOR

had three times bronchoscopy one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period to confirm both clinical and bacteriological cure. Bronchoscopy done with the following precautions: we used flexible bronchoscopy Olympus BF-160 adult size, patients kept sedated with both midazolam and fentanyl, 4 syringe of normal isotonic saline used for wash every one 10 ml and suction done immediately after injection, suction of the fluid and small airway secretion after only the first injection of isotonic saline syringe used for BAL and sent for qualitative culture

Drug: Meropenem; Procedure: bronchoscopy; Device: ventilator

Interventions

Meropenem DRUG

all patients in both groups receive meropenam and put on the ventilators for 2 weeks

Group A; Group B

bronchoscopy PROCEDURE

Only patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period

Group B

ventilator DEVICE

ventilator

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: only adult patients from both sexes
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with age group between 18-65 years,patients Respiratory failure, patients with pneumonia

You may not qualify if:

• pediatric patients, patients with anoxic brain insult

Sponsors & Collaborators

• King Abdul Aziz Specialist Hospital: lead

Study Sites (1)

King abd el Aziz specialist hospital

Ta'if, 21944, Saudi Arabia

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Meropenem; Bronchoscopy; Ventilators, Mechanical

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 200 patients included in our study from those who showed no improvement and still had respiratory failure and completed ventilation for 4 days and fulfilled \> 2 parameters on SOFA score \[9-10\] and \> 6 on CPIS score and randomly allocated in two groups 100 patients in each.

Study Record Dates

• First Submitted: September 13, 2020
• First Posted: September 17, 2020
• Study Start: July 2, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-04

Locations

SA (1)