| CTRI Number |
CTRI/2023/05/052530 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
02/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of dexmed vs midazolam infusion on inflammatory biomarkers in sepsis patients |
|
Scientific Title of Study
|
Randomised comparative clinical study of effects of dexmetomidine infusion vs midazolam infusion on inflammatory biomarkers in patients with sepsis requring mechanical ventilation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Diksha Choudhary |
| Designation |
Junior resident |
| Affiliation |
Swami Vivekanand Subharti medical university |
| Address |
Department of Anaethesiology, Subharti Medical College and hospital , Meerut
UTTAR PRADESH
250001 INDIA
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9779867399 |
| Fax |
|
| Email |
diksha5795@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrProf Bhawana Rastogi |
| Designation |
Professor and Head of Department |
| Affiliation |
Swami Vivekanand Subharti Medical University |
| Address |
Department of Anaethesiology,
Subharti Medical College and hospital , Meerut
UTTAR PRADESH
250001 INDIA
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9528615505 |
| Fax |
|
| Email |
28bhawana75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Diksha Choudhary |
| Designation |
Junior resident |
| Affiliation |
Swami Vivekanand Subharti medical university |
| Address |
Department of Anaethesiology, Subharti Medical College and hospital , Meerut
UTTAR PRADESH
250005 INDIA
C-155 GROUND FLOOR, ASHOKA ENCLAVE-2SECTOR-37 ,AMARNAGAR , FARIDABAD , HARYANA
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9779867399 |
| Fax |
|
| Email |
diksha5795@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Vivekanand Subharti University, Meerut |
|
|
Primary Sponsor
|
| Name |
DIKSHA CHOUDHARY |
| Address |
Begum hazrat mahal hospital, Subharti medical college,Subhartipuram, NH-58, Delhi-Haridwar, Meerut Bypass Rd, Meerut, Uttar Pradesh 250005 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Swami Vivekanand Subharti Medical College |
Subhartipuram, NH-58, Delhi-Haridwar, Meerut Bypass Rd, Meerut, Uttar Pradesh 250005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Diksha Choudhary |
Subharti Medical College and hospital |
Subhartipuram, NH-58, Delhi-Haridwar, Meerut Bypass Rd, Meerut, Uttar Pradesh 250005
Meerut
UTTAR PRADESH |
9779867399
diksha5795@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE (MEDICAL) SWAMI VIVEKANAND SUBHARTI UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DEXMETOMIDINE |
DEXMETOMIDINE INFUSION ON INFLAMMATORY BIOMARKERS IN SEPSIS REQUIRING MECHANICAL VENTILATION |
| Intervention |
INFLAMMATORY BIOMARKERS CRP,IL-6 and lactate level |
INFLAMMATORY BIOMARKERS IN SEPSIS REQUIRING MECHANICAL VENTILATION |
| Comparator Agent |
MIDAZOLAM |
MIDAZOLAM INFUSION ON INFLAMMATORY BIOMARKERS IN SEPSIS REQUIRING MECHANICAL VENTILATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
In sepsis (patient fulfilling SIRS criteria of sepsis).
Patient on mechanical ventilation.
Patient having sequential organ failure assessment (SOFA) score of 2 or more.
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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
|
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. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 16-03-2023 and end date provided 15-08-2024?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
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 |