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

Randomised comparative clinical study of effects of dexmetomidine infusion vs midazolam infusion on inflammatory biomarkers in patients with sepsis requring mechanical ventilation

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/052530

Enrollment

Registered

2023-05-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: INFLAMMATORY BIOMARKERS CRP,IL-6 and lactate level: INFLAMMATORY BIOMARKERS IN SEPSIS REQUIRING MECHANICAL VENTILATION Control Intervention1: DEXMETOMIDINE: DEXMETOMIDINE INFUSION ON IN

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
To compare the effect of Dexmetomidine infusion with Midazolam infusion on inflammatory markers like CRP, IL-6 and lactate levels.Timepoint: 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

Measure	Time frame
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 Timepoint: Mechanical ventilation days and length of ICU days will also be recorded CRP, IL-6 and Lactate levels to be done on day 0 ,2 and 5 of ICU admission and on mechanical ventilation.	—

Measure

Time frame

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 Timepoint: Mechanical ventilation days and length of ICU days will also be recorded CRP, IL-6 and Lactate levels to be done on day 0 ,2 and 5 of ICU admission and on mechanical ventilation.

—

Countries

India

Contacts

Public ContactDiksha Choudhary

Swami Vivekanand Subharti Medical University

28bhawana75@gmail.com9528615505

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026