Status:
COMPLETED
Efficacy of PMZ-2010 (Centhaquine) a Resuscitative Agent for Hypovolemic Shock
Lead Sponsor:
Pharmazz, Inc.
Conditions:
Hypovolemic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-III efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock. Centhaquine (previously ...
Detailed Description
Approximately 105 patients will be randomized 2:1 into 2 treatment groups after meeting the eligibility criteria. Total 70 patients will be enrolled in PMZ-2010 group (Group 1) and in Normal Saline gr...
Eligibility Criteria
Inclusion
- Patients with hypovolemic shock admitted to the emergency room or ICU with systolic blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment. Blood Lactate level indicative of hypovolemic shock (\>2.0 mmol/L).
Exclusion
- Development of any other terminal illness not associated with Hypovolemic shock during the 28-day observation period.
- Patient with altered consciousness not due to Hypovolemic shock.
- Known pregnancy.
- Cardiopulmonary resuscitation (CPR) before randomization.
- Presence of a do not resuscitate order.
- Patient is participating in another interventional study.
- Patients with systemic diseases which were already present before having trauma, such as: cancer, chronic renal failure, liver failure, decompensated heart failure or AIDS.
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2019
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04045327
Start Date
January 31 2019
End Date
September 27 2019
Last Update
October 4 2019
Active Locations (18)
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1
Seven Star Hospital
Nagpur, Maha, India
2
Jawahar Lal Nehru Medical College & Attached Hospitals
Ajmer, India, 305001
3
Radiant Superspeciality Hospital
Amravati, India, 444606
4
People Tree Hospitals
Bangalore, India, 560022