Effect of dexmed vs midazolam infusion on inflammatory biomarkers in sepsis patients

Phase 1/2

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/05/052530
• Lead Sponsor: DIKSHA CHOUDHARY

Brief Summary

This study is randomized , double blind parallel group single centre trial comparing effects of dexmetomidine and midazolam infusion on inflammatory biomarkers in patients with sepsis requiring mechanical ventilator  18 months in 60 patients. The primary outcome measures To compare the effect of Dexmetomidine infusion with Midazolam infusion on inflammatory markers like CRP, IL-6 and lactate levels.with secondary outcome

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-05
• Study Start: 2023-05-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• In sepsis (patient fulfilling SIRS criteria of sepsis).
• Patient on mechanical ventilation.
• Patient having sequential organ failure assessment (SOFA) score of 2 or more.

Exclusion Criteria

• 1.Patients with history of severe cardiac or pulmonary disease, poorly controlled hypertension. 2.Known hypersensitivity to study drugs or using any drug that modifies pain perception. 3.Refusal to participate 4.Have unpaced second or third degree heart block 5.Have uncontrolled hypotension 6.Have acute cerebrovascular conditions 7.Concurrently using other alpha-2 agonists, eg, clonidine 8.Cautions for the following patients who are:.
• a.Are at risk of exaggerated cardiovascular response, e.g., hypovolaemia b.Have spinal cord injury c.Have severe left ventricular systolic dysfunction d.Are pregnant e.Breast-feeding f.Have seizures disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect of Dexmetomidine infusion with Midazolam infusion on inflammatory markers like CRP, IL-6 and lactate levels.	as per study protocol CRP, IL-6 and Lactate levels to be done on day 0 ,2 and 5 of ICU admission and on mechanical ventilation.

Secondary Outcome Measures

Name	Time	Method
To compare the effect of Dexmetomidine infusion with Midazolam infusion on number of days on mechanical ventilation, length of ICU stays, nutrition (by albumin levels) platelet count and INR (coagulopathy).	Adverse effects if any

Trial Locations

Locations (1)

Subharti Medical College and hospital; 🇮🇳 Meerut, UTTAR PRADESH, India

Subharti Medical College and hospital

🇮🇳Meerut, UTTAR PRADESH, India

Diksha Choudhary

Principal investigator

9779867399

diksha5795@gmail.com