| CTRI Number |
CTRI/2023/12/060444 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of centhaquine on cardiovascular parameters in patients with
hypovolemic shock. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled pilot study to evaluate the effect of centhaquine on cardiovascular parameters in patients with hypovolemic shock. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Aman_Lyfa_PS-01 / Version 1.0, Dated 1 September 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAman Khanna |
| Designation |
Principal Investigator |
| Affiliation |
Aman Hospital and Research Centre |
| Address |
Aman Hospital and Research Centre,
Clinical Research Department
Ground Floor,
15 Shashwat, Opp E.S.I Hospital,
Gotri Road, Vadodara, Gujarat – 390021
Vadodara
GUJARAT
390021
India |
| Phone |
9904402122 |
| Fax |
|
| Email |
amankhanna170974@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aman Khanna |
| Designation |
Principal Investigator |
| Affiliation |
Aman Hospital and Research Centre |
| Address |
Aman Hospital and Research Centre, Ground Floor, Clinical Reserach Department,
15 Shashwat, Opp E.S.I Hospital,
Gotri Road, Vadodara, Gujarat – 390021
Vadodara
GUJARAT
390021
India |
| Phone |
9904402122 |
| Fax |
|
| Email |
amankhanna170974@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAman Khanna |
| Designation |
Principal Investigator |
| Affiliation |
Aman Hospital and Research Centre |
| Address |
Aman Hospital and Research Centre,
Clinical Research Department,
Ground Floor,
15 Shashwat, Opp E.S.I Hospital,
Gotri Road, Vadodara, Gujarat – 390021
Vadodara
GUJARAT
390021
India |
| Phone |
9904402122 |
| Fax |
|
| Email |
amankhanna170974@gmail.com |
|
|
Source of Monetary or Material Support
|
| Clinical Research Department, Ground Floor,
Aman Hospital and Research Centre.
15 Shashwat, Opp E.S.I Hospital,
Gotri Road, Vadodara, Gujarat – 390021
|
|
|
Primary Sponsor
|
| Name |
Aman Hospital and Research Centre |
| Address |
Aman Hospital and Research Centre, Clinical Research Department, Ground Floor,
15 Shashwat, Opp E.S.I Hospital,
Gotri Road, Vadodara, Gujarat – 390021
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Aman Khanna |
Aman Hospital and Research Centre, |
Clinical Research Department, Ground floor,
15 Shashwat, Opp E.S.I Hospital,
Gotri Road, Vadodara, Gujarat – 390021
Vadodara
GUJARAT |
9904402122
amankhanna170974@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aman Hospital and Research Centre 15 Shashwat, Opp, E.S.I Hospital Sarabhai, Gotri Road Vadodara Gujarat - 390021 India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I958||Other hypotension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Centhaquine |
Centhaquine (Dose: 0.003 mg/kg x 3 doses per day) + Standard
of care. Patients will be treated for a total of 24 hours. 3 doses of 0.003mg/kg centhaquine at 4 hours of intervals along with standard of care (SOC) will be administered. |
| Comparator Agent |
Normal Saline |
Equal volume Normal saline + Standard of care.
Patents will be treated for a total of 24 hours. 3 doses of placebo(equal volume of Normal saline) at 4 hours of intervals along with standard of care (SOC) will be administered. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
• Adult males or females aged 18 years or older.
• Subjects with hypovolemic shock admitted to the hospital with systolic
blood pressure ≤ 90 mmHg at presentation and continue to receive
standard treatment of shock (endotracheal intubation; fluid resuscitation,
and vasopressors). The best available standard of care to be provided to the
subject.
• Blood lactate level indicative of hypovolemic shock with lactate level more
than 2 mmol/L.
• Informed consent provided by the patient or legally authorised
representative of the patient |
|
| ExclusionCriteria |
| Details |
1. Subject with illness clinically defined as septic shock (confirmed or
suspected acute infection), cardiogenic shock, neurogenic shock.
2.Subject for whom an etiology for hypovolemic shock cannot be determined
on initial evaluation.
3. Hypovolemic shock due to traumatic brain injury including any significant
CNS injury, traumatic tamponade, traumatic tension pneumothorax, ventricular wall rupture.
4. Patient with altered consciousness not due to hypovolemic shock.
5. Subject with confirmed pregnancy.
6. Cardiopulmonary resuscitation (CPR) before randomization.
7. Presence of a do not resuscitate order.
8. Patient is participating in another interventional study.
9. Patients with a history of systemic disease (chronic renal failure, liver failure, decompensated heart failure) or any terminal illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) |
Time frame: 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Stroke Volume (SV) |
Before and 1h after each IP
administration. |
| Change in cardiac output (CO) |
Before and 1h after each IP
administration. |
Proportion of patients with an increase in Mean Arterial Pressure (MAP)
from baseline of at least 10 mmHg |
Time frame: 24 hours |
| Change in Mean Arterial Pressure (MAP) |
Mean through 24 hours |
| Change in Heart Rate (HR) |
Mean through 24 hours |
| Change in blood lactate |
Mean through 24 hours |
| Amount of fluid (crystalloids and colloids) infused |
Mean through 24 hours |
| Amounts of vasopressor(s) infused |
Mean through 24 hours |
| Total Urine output |
Time frame: 24 Hours] |
| Proportion of patients with adverse events (AEs) and serious adverse events (SAEs) |
Through out study period |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2023 |
| Date of Study Completion (India) |
18/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This is a randomized, double-blind, placebo-controlled pilot study to evaluate
the effect of centhaquine on cardiovascular parameters in patients with
hypovolemic shock.
After obtaining institutional ethics committee clearance and written informed
consent, patients fulfilling the eligibility criteria will be enrolled in the study.
20 eligible patients diagnosed with hypovolemic shock with systolic arterial
blood pressure ≤ 90 mmHg at presentation, will be allotted into two groups of
10 each and randomly assigned in 1:1 ratio to receive either centhaquine
0.003mg/kg (Group 1) or placebo (Group 2). They will be treated for a total of
24 hours. 3 doses of 0.003mg/kg centhaquine or placebo at 4 hours of intervals
along with standard of care (SOC) will be administered.
• Group 1: Centhaquine (Dose: 0.003 mg/kg x 3 doses per day) + Standard
of care
• Group 2: Placebo (Dose: equal volume saline) + Standard of care
In both treatment groups, subjects will be provided with standard of care.
Centhaquine or placebo will be administered intravenously after randomization
to hypovolemic shock subjects with systolic arterial blood pressure ≤ 90 mmHg
at presentation and continue to receive standard treatment of shock. In the
centhaquine group, three doses of centhaquine (0.003 mg/kg) at 4 hours of
intervals will be administered as an intravenous infusion over 1 hour in 100 mL
normal saline. Placebo group will be administered equal volume of normal
saline as an intravenous (IV) infusion over 1 hour. Condition of administration
will remain same as for centhaquine group. All subjects will be closely
monitored during and after infusion. Vital signs will be monitored every 10
minutes during infusion. In the event of worsening hemodynamics or
respiratory status, the infusion will be discontinued. Each subject will also be
monitored closely throughout his/her hospitalization and will be followed until
discharge from randomization. Each subject will be assessed for cardiovascular
parameters such as blood pressure, heart rate, cardiac output, mean arterial
pressure and stroke volume. Adverse events will be monitored for safety
parameters |