| CTRI Number |
CTRI/2025/09/093958 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to observe the effect of a protocolized removal of excess fluid on the integrity of small blood vessel lining in patients with sepsis |
|
Scientific Title of Study
|
Effect of Protocolized De-resuscitation on Endothelial Glycocalyx Degradation Products
in Critically Ill Adult Patients with Sepsis: A prospective observational study effect of protocol |
| 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 Sulagna Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 5018 A, 5th floor, teaching block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
01126593212 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sulagna Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 5018 A, 5th floor, teaching block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
01126593212 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sulagna Bhattacharjee |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room no 5018 A, 5th floor, teaching block, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
01126593212 |
| Fax |
|
| Email |
bhattacharjee.sulagna85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural grant, Research section, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
research section, AIIMS, New Delhi |
| Address |
Research section, 1st floor, JNL auditorium, AIIMS, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sulagna Bhattacharjee |
All India Institute of Medical Sciences, New Delhi |
AB8 ICU and surgical ICU
South
DELHI |
919818212531
bhattacharjee.sulagna85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstituteEthics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Critically ill patients with sepsis and septic shock, mechanically ventilated patients with iatrogenic volume overload requiring de-resuscitation. Volume overload will be identified by cumulative positive fluid balance of more than 10 percent body weight and / or by clinical signs of fluid overload like in lungs (chest Xray, lung ultrasound ), venous excess
ultrasound grade more than 0, of will be included. |
|
| ExclusionCriteria |
| Details |
1. Refusal to participate
2. Pregnancy or post- partum up to 6 weeks
3. Patients who are requiring vasopressor/ inotrope more than norepinephrine dose of 0.2 micrograms per kg per min or equivalent doses.
4. Hypernatremia more than 155 meq/L
5. Receiving renal replacement therapy
6. Patients with medical conditions like diabetic ketoacidosis, hyperosmolar
hyperglycemic states, nontraumatic subarachnoid hemorrhage.
7. Acute cardiogenic shock
8. Known allergy to the drugs used |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to compare serum hyaluronan level before
and after ‘protocolized de-resuscitation’ in critically ill mechanically ventilated
adult patients with iatrogenic volume overload |
Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare syndecan-1, VE- Cadherin, bio- adrenomedullin and heparan
sulphate level before and after ‘protocolized de-resuscitation’.
2. To compare ESR & C- reactive protein level before and after ‘protocolized
de-resuscitation’.
3. To compare serum albumin level before and after ‘protocolized deresuscitation’.
4. To compare serum urea and creatine before and after ‘protocolized deresuscitation’.
5. To know the association between change in glycocalyx degradation product
and intensive care unit stay since recruitment in this study.
6. To know the association between change in glycocalyx degradation product
and negative fluid balance since recruitment in this study.
|
Day 3 |
7. To know the association between change in glycocalyx degradation product
and survival to ICU discharge |
Upto day 30 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
12/09/2025 |
| 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="2"
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 - NO
|
|
Brief Summary
|
In this observation study in 70 adult critically ill adult patients with sepsis/septic shock, who have been advised for protocolized deresuscitation by the treating physician with albumin and furosemide, we will study the effect of deresucitation on endothelial glycocalyx degradation products like serum hyaluronan, syndecan, VE cadherin, bioadrenomedulin as well as renal function parameters and clinical outcome like survival to ICU discharge. Our hypothesis is that, dersusciation will hep to preserve endothelial glycocalyx integrity and will correlate with improvement in organ function. |