| CTRI Number |
CTRI/2024/11/076879 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effects of inhaled nitric oxide used for lungs hypertension in critically ill patients.
|
|
Scientific Title of Study
|
Study of systemic and pulmonary hemodynamic effects of inahaled nitric oxide used for pulmonary arterial hypertension in critically ill patients. |
| Trial Acronym |
Nitroccm |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujeet Rai |
| Designation |
Professor |
| Affiliation |
Dr. RMLIMS LUCKNOW |
| Address |
Department of Anaesthesiology Dr.RMLIMS LUCKNOW Room No. 9
Administrative Block Lucknow UTTAR PRADESH 226010 India
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9161758940 |
| Fax |
|
| Email |
drsujeetrai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujeet Rai |
| Designation |
Professor |
| Affiliation |
Dr. RMLIMS LUCKNOW |
| Address |
Department of Anaesthesiology Dr.RMLIMS LUCKNOW Room No. 9
Administrative Block Lucknow UTTAR PRADESH 226010 India
UTTAR PRADESH
226010
India |
| Phone |
9161758940 |
| Fax |
|
| Email |
drsujeetrai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Brahamdutt sharma |
| Designation |
junior resident |
| Affiliation |
Dr. RMLIMS LUCKNOW |
| Address |
Dr RMLIMS Room no 615 Vibhuti khand gomati Nagar Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9315826276 |
| Fax |
|
| Email |
brahamduttsha15@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr RMLIMS Lucknow , Vibhuti Khand , Gomti Nagar , Lucknow , Uttar Pradesh, pin code 226010, India. |
|
|
Primary Sponsor
|
| Name |
Dr SUJEET RAI |
| Address |
Dr RMLIMS Lucknow, Vibhuti khand, Gomti Nagar , lucknow pin code 226010, India |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujeet Rai |
Dr Ram Manohar lohia Institute of Medical Sciences |
Department of
Anesthesiology and
CCM ,Administartive
Building ,DR RMLIMS
Lucknow , Vibhuti
khand , Gomti Nagar
Lucknow.
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
9161758940
drsujeetrai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr.RMLIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inhaled Nitric oxide |
Continous inhaled nitric oxide via nitric oxide delivery device. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18-65 years of age admitted in ICU with pulmonary
hypertension and left sided heart failure |
|
| ExclusionCriteria |
| Details |
Declined consent from guardian
Patients with an increased bleeding risk (or) active bleeding due to
vascular damage
Allergic reaction to any drug
Pregnancy and nursing period.
Valvular heart disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Determine the effect of nitric oxide on pulmonary and
systemic circulation on patients admitted in ICU |
From the day of admission to next 72 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Determine the effect of nitric oxide on right heart failure
in pulmonary hypertension patients |
From the day of admission to next 72 hours. |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIMS AND OBJECTIVES Primary Objective- ï‚· To determine the effect of nitric oxide on pulmonary and systemic circulation on patients admitted in ICU Secondary Objective- ï‚· To determine the effect of nitric oxideon right heart failure in pulmonary hypertension patients |