| CTRI Number |
CTRI/2025/01/078960 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To determine clinicoepidemiological characteristics and to evaluate the safety and effectiveness of Polygeline in patients with Hypovolemia |
|
Scientific Title of Study
|
A Prospective, multicenter Observational Study to Determine the clinicoepidemiological profile of Indian Patients Presenting with Hypovolemia and to evaluate the Safety and effectiveness of Polygeline |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PSPC-524-0465, version no.1.0, dated 16 September 2024 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Mr Jamnadas Kushwaha |
| Designation |
Head-CT |
| Affiliation |
Raptim Research private Ltd |
| Address |
A-242,A-226, TTC Industrial Area, Near Mahape Depot, Mahape MIDC, Navi Mumbai
Thane
MAHARASHTRA
400710
India |
| Phone |
9819475207 |
| Fax |
|
| Email |
jamnadas.kushwaha@raptimresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kartik Peethambaran |
| Designation |
Associate Director - Medical Affairs |
| Affiliation |
Abbott Healthcare Private Limited, |
| Address |
Floor 18, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East,
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8454041733 |
| Fax |
|
| Email |
kartik.peethambaran@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Director Clinical Development & Operations |
| Affiliation |
Abbott Healthcare Private Limited |
| Address |
Floor 17-18, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East,
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8657552543 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Private Limited Floor 17-18, Godrej BKC, Plot No C-68, Bandra Kurla Complex, Bandra East, Mumbai-400051, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Private Limited |
| Address |
Floor 17, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051, India.
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajai Singh |
All India Institute of Medical Science (AIIMS) |
MRU unit, nursing building, Ground floor, Saket Nagar, 462020
Bhopal
MADHYA PRADESH |
6387859355
director@aiimsbhopal.edu.in |
| Dr Sanjay Shah |
Apollo Hospitals International Limited |
Plot No, 1A, Gandhinagar - Ahmedabad Rd, GIDC Bhat, estate, 382428
Gandhinagar
GUJARAT |
9898000265
drsanjayshah2002@yahoo.com |
| Dr Sarang Vyawahare |
Ishwar Institute of Healthcare |
Ishwar Heights, 1st Floor, plot no. 7, gut no. 6/, beside Punjabi Bhavan, Padegaon, 431002 India
Aurangabad
MAHARASHTRA |
9209999300
ishwarhealthcare@gmail.com |
| Dr Vijaykumar Khandale |
Maeers Vishwaraj Hospital |
Gate No. 499, Kadamwakwasti Solapur Road, Loni, Kolbhor 412201 India
Pune
MAHARASHTRA |
9869743976
drvijaykhandale@gmail.com |
| Dr Krishna Murty |
Subharti Medical College & Hospital |
Subharti Medical College & Hospital Medicine, Subhartipuram NH-58 Delhi-Haridwar Bypass Road,250005
Meerut
UTTAR PRADESH |
9639010152
krishnasubhartioffice@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| All India Institute of Medical Sciences Bhopal Institutional Human Ethics Committee |
Approved |
| Ethics Committee of Ishwar Institute of HealthCare |
Approved |
| IEC Maeers Vishwaraj Hospital |
Approved |
| Institutional Ethics Committe-Apollo Hospital International Ltd |
Approved |
| Institutional Ethics Committee Subharti Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E861||Hypovolemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Polygeline 3.5% IV Infusion |
Dose is 3.5%, duration is for 24 hours and route of administration is IV. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The subjects will be included in the study based on the following criteria
1. Male and female patient’s ≥18 to 65 years of age.
2. Informed consent will be primarily obtained from patient’s Legally Acceptable Representative (LAR) or patient themselves when they could give consent.
3. Adult patients who present with symptoms of hypovolemia and who have been prescribed IV Polygeline as per the discretion of the investigator will be included in the study.
4. Patients presenting with Class II or III of hypovolemia due to hemorrhage (per Advanced Trauma Life Support criteria of acute hemorrhage).
|
|
| ExclusionCriteria |
| Details |
The subject will be excluded from the study if they meet any of the following criteria:
1. Patients with hypersensitivity to Polygeline or any other constituent.
2. Pregnant and breast-feeding women, patients with concomitant asthma and unconscious patients.
3. Patients who are critically ill, as per the discretion of the investigator.
4. Patients who have been given Hydroxyethyl starch (HES), Albumin, other gelatins (gelofusine) or any other kind of synthetic colloid.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Demographic profile - Age, gender, education and occupation.
2. Clinico-epidemiological – Classification of hypovolemia, volume of blood loss, cause of hypovolemia.
|
24 Hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine effectiveness
A. Change from baseline at every hour till 6 hrs. and then at 10 hrs., 14 hrs., 18 hrs. and 24 hrs.
1. Blood pressure – Systolic, Diastolic and mean arterial
2. Respiratory rate
3. Pulse rate
4. Urine output
5. Pallor and condition of skin (cold, clammy)
B. Change from baseline at 12 hrs. and 24 hrs. for the following parameters:
1. Arterial pH
2. Bicarbonate levels
3. Blood lactate
4. Anion Gap
|
24Hrs |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="154" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/01/2025 |
| Date of Study Completion (India) |
05/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Post-Marketing Observational Study to determine the clinicoepidemiological characteristics in Indian Patients Presenting with Hypovolemia and to evaluate the Safety and effectiveness of Polygeline There is only one visit in the study i.e., Screening, Enrolment and Treatment on the same day |