| CTRI Number |
CTRI/2023/05/053056 [Registered on: 23/05/2023] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal |
| Study Design |
Other |
|
Public Title of Study
|
Can serum value of NT-proBNP be used in predicting patient outcome for those with preeclampsia admitted to ICU |
|
Scientific Title of Study
|
Serum NT-proBNP (N-terminal propeptide Brain-type Natriuretic Peptide) as a Prognostic Marker in Patients with Preeclampsia admitted to Intensive Care Unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asha Tyagi |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Dilshad Garden, Shahdra
East
DELHI
110095
India |
| Phone |
|
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asha Tyagi |
| Designation |
Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Dilshad Garden, Shahdra
East
DELHI
110095
India |
| Phone |
|
| Fax |
|
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Gupta |
| Designation |
1st year PG student |
| Affiliation |
University college of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care, UCMS and GTB Hospital, Dilshad Garden, Shahdra
East
DELHI
110095
India |
| Phone |
|
| Fax |
|
| Email |
dgupta10111997@gmail.com |
|
|
Source of Monetary or Material Support
|
| University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Shahdra, Delhi-110095 |
|
|
Primary Sponsor
|
| Name |
UCMS and GTB Hospital |
| Address |
Dilshad Garden, Shahdra, Delhi-110095 |
| Type of Sponsor |
Government medical college |
|
|
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 Divya Gupta |
UCMS and GTB Hospital |
Department of Anaesthesiology and Critical Care, Dilshad Garden, Shahdra
East
DELHI |
9953570377
dgupta10111997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O14||Pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All preeclamptic obstetric patients (pregnant or within 6 weeks postdelivery), admitted to our multidisciplinary ICU will be included. Diagnosis of preeclampsia will be made as per existing guidelines of American College of Obstetricians and Gynaecologists |
|
| ExclusionCriteria |
| Details |
Those with history of prior cardiac disease or renal disease will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Death |
Will be evaluated daily, starting from day of admission in ICU till end of hospital stay. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of ICU stay (days) |
From day of ICU admission till discharge/death in ICU |
|
|
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)
|
31/05/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rationale: There appears to be limited data however evaluating use of NT-proBNP for prognostication of maternal outcome in pregnant patients. In resource limited or constrained setups, risk stratification of patients with preeclampsia may help to prioritise care, aid triage decision making and optimise allocation of resources. Aim: To evaluate the role of serum NT-proBNP as a predictor of clinical outcome in patients of preeclampsia admitted to ICU. Primary objective: To evaluate the role of serum NT-proBNP for predicting In-hospital mortality of patients with preeclampsia admitted to ICU. Secondary objectives: To evaluate the role of serum NT-proBNP for predicting the following in patients with preeclampsia admitted to ICU: duration of ICU stay, need of postoperative mechanical ventilation, complications attributable to preeclampsia. Materials and Methods: All preeclamptic obstetric patients (pregnant or within 6 weeks post-delivery), admitted to our multidisciplinary ICU will be included. After discharge from ICU, patients will be followed for the entire hospital stay for assessing In-hospital mortality. Primary outcome measure will be the in-hospital mortality for its association with NT-proBNP at time of ICU admission. Additionally, a longitudinal trend for changes in NT-proBNP will also be compared amongst survivors and non-survivors, by measuring the levels on 1 st and 3 rd day of ICU admission as well. The evaluation of NT-proBNP will be done by an investigator not otherwise involved in the clinical care of the patient.
Statistical analysis: Statistical tests will be applied using the SPSS software and P- value less than 0.05 will be considered significant. The discriminating ability of NT-ProBNP for patient mortality will be analysed using receiver operating characteristics (ROC) with corresponding area under the curve. Qualitative data will be represented as percentage and quantitative data will be reported as mean ± SD for normally distributed data, or median [IQR] for non- normally distributed data. Other tests will be used as deemed appropriate. |