| CTRI Number |
CTRI/2016/11/007422 [Registered on: 02/11/2016] Trial Registered Retrospectively |
| Last Modified On: |
29/12/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Relation of abdominal pressure to kidney function |
|
Scientific Title of Study
|
Role of Intra-Abdominal Pressure in Acute Kidney Injury in Critically Ill Obstetric Patients: A Prospective Cohort Study. |
| Trial Acronym |
|
|
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 |
Director Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care; University College of Medical Sciences and GTB Hospital Dilshad Garden
East
DELHI
110095
India |
| Phone |
9818606404 |
| Fax |
- |
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asha Tyagi |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care; University College of Medical Sciences and GTB Hospital Dilshad Garden
East
DELHI
110095
India |
| Phone |
9818606404 |
| Fax |
- |
| Email |
drashatyagi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asha Tyagi |
| Designation |
Director Professor |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Anaesthesiology and Critical Care; University College of Medical Sciences and GTB Hospital Dilshad Garden
East
DELHI
110095
India |
| Phone |
9818606404 |
| Fax |
- |
| Email |
drashatyagi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care, University College of Medical Sciences and GTB Hospital
Dilshad Garden
Shahdra
Delhi-95 |
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences and GTB Hospital |
| Address |
University College of Medical Sciences and GTB Hospital Dilshad Garden Delhi |
| 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 Asha Tyagi |
University College of Medical Sciences and GTB Hospital |
Department of Anesthesiology and Critical Care
Dilshad Garden
Shahdra
Delhi-95
East
DELHI |
9818606404
drashatyagi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- Human Research University College of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Critically ill Obstetric patients i.e., those pregnant patients or those within 6 weeks of delivery who require admission to the
ICU, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Female |
| Details |
1. Obstetric patients admitted to ICU, with
2. Pregnancy or upto 6 weeks post delivery,
3. For causes related directly to pregnancy such as preeclampsia, haemorrhage etc. or
4. For causes related indirectly to pregnancy such as worsening of diabetes, sepsis etc.
5. Needing an indwelling urinary Foley catheter. |
|
| ExclusionCriteria |
| Details |
1. Patients with an anticipated duration of stay in ICU of <24 hours,
2. Those not needing a urinary Foley catheter,
3. Or with any contraindication to IAP measurement such as bladder injury or pelvic fracture. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EARLY AKI (acute kidney injury) (Diagnosed by Urine output and serum Creatinine) |
Every 24 hours for first two days of ICU stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intra- Abdominal Pressure
Urinary NGAL
SOFA score
ICU mortality and duration of stay |
Daily for the entire duration of ICU stay
At the time of ICU admission
Daily for first two days of ICU stay
Daily for entire duration of ICU stay |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2016 |
| Date of Study Completion (India) |
27/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Intra-abdominal pressure (IAP) of critically ill obstetric patients who are admitted to the ICU will be measured using the intra-vesicle or bladder method, considered as the gold standard technique for measuring IAP. This involves use of an external manometer/ transducer connected to indwelling Foley bladder catheter. Also, the incidence of early Acute Kidney Injury (AKI) (within first 2 days of ICU stay) will be evaluated using the pre-defined criteria with serum creatinine/ urine output. The relation between IAP values and AKI would be sought. Also the role of urinary NGAL (Neutrophil Gelatin Associated Lipocalin) in predicting AKI will be evaluated, for which patient’s urine sample will be collected at the time of ICU admission, centrifuged and stored at -80°C for future assay with ELISA kit. The sequential organ failure assessment (SOFA) severity illness score for the first 2 days of ICU stay, and mortality as well as duration of stay in ICU will also be recorded. |