| CTRI Number |
CTRI/2024/08/071923 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Red cell distribution width as a prognostic marker for mortality in Respiratry Intensive care unit in patients with Acute Respiratory failure requiring mechanical ventilation |
|
Scientific Title of Study
|
Red cell distribution width as a predictor of mortality in critically ill patients with Acute Respiratory failure requring mechanical ventilation in Respiratory intensive care unit in a Teritiary care teaching hospital -A Prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhavana Dhakshinapu |
| Designation |
MBBS,Post graduation(MD) Anaesthesiology and critical care medicine |
| Affiliation |
Sri Venkateswara Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology,
Sri Padmavathi Women hospital,SVIMS,Tirupati.
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
7013884198 |
| Fax |
|
| Email |
bhavanavenkatesh978@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRAloka Samantharay |
| Designation |
Professor and Head of department,Department of Anaesthesiology |
| Affiliation |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,SVIMS,Alipiri,Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRAloka Samantharay |
| Designation |
Professor and Head of Department ,Department of Anaesthesiology |
| Affiliation |
Sri Venkateswara Institute of medical sciences |
| Address |
Department of Anaesthesiology,SVIMS,Alipiri,Tirupati
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical sciences, Tirupati, Andra pradesh,India. Pincode-517507 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| 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 |
| DrBhavana Dhakshinapu |
Sri Venkateswara Institute of Medical sciences |
Department of Anaesthesiology
SVIMS, Alipiri, Tirupati
Chittoor
ANDHRA PRADESH |
7013884198
bhavanavenkatesh978@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients of more than 18 years of age
Patients with acute respiratory failure who require mechanical ventilation and get admitted to respiratory intensive care unit
Patients who develop acute resoiratory failure during stay in respiratory intensive care unit and require mechanical ventilation |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in the study
Pregnancy and Lactating women
Patients who were intubated elsewhere and shifted to our hospital
Patients who transferred to another intensive care and lost follow up
Length of stay less than 24 hrs in Respiratory intensive care unit
White blood cell count less than 1000cells/ml
Solid or Haematological tumour requiring immune supression and outpatient steroid or radiotherapy
History of packed RBC transfution in the previous week |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess red cell distribution width at admission as a marker to predict mortality in patients with Acute Respiratory Failure requiring mechanical ventilation |
To assess red cell distribution width at admission that is base line and 48 hours after admission as a marker to predict mortality in patients with Acute Respiratory Failure requiring mechanical ventilation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the Red cell distribution width with well known scoring systems (apache ii,SOFA)in predicting mortality
To study the change in rdw at 48 hours in predicting the outcome of patients |
to compare red cell distribution width with APACHEII & sofa AT admission that is base line & after 48 hours after admission
to study the change in RDW at 48 hours in predicting the outcome of patients |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
13/08/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhavanavenkatesh978@gmail.com].
- For how long will this data be available start date provided 08-08-2024 and end date provided 07-08-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Acute Respiratory Failure is a common critical clinical syndrome in Intensive care units caused by multitide of pathological state with a mortality of about 36 % Acute Respiratory Failure implies an inability to maintain adequate oxygenation to tissues or adequate removal of co2 from tissues Red cell distribution width (rdw) is a measure of variation in red blood cell volume that is routinely reported in complete haemogram ,any process that realeses reticulocytes into the circulation will result in an increase in Red cell distribution width Transient decrease in oxygen partial pressure will lead to pulsed erythropoietin release through hypoxia inducible transcription factors ,these inturn release of immature reticulocytes into circulation leading to anisocytosis and higher rdw elevated RDW at admission was associated with early mortality and worse longterm outcome RDW will be measured in patient with acute respiratory failure requiring mechanical ventilation within 6 hrs of intubation and after 48 hours of intubation and will be compared to APACHE II ans SOFA score which were measured at admission and 48 hours for predicting mortality |