Status:
COMPLETED
PMZ-2010 (Centhaquine) as a Resuscitative Agent for Hypovolemic Shock
Lead Sponsor:
Pharmazz, Inc.
Conditions:
Hypovolemic Shock
Blood Loss
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-II efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock. Centhaquine is highly saf...
Detailed Description
Centhaquine (previously used names, centhaquin and PMZ-2010; International Non-proprietary Name (INN) recently approved by WHO is centhaquine) has been found to be an effective resuscitative agent in ...
Eligibility Criteria
Inclusion
- Adult males or females aged 18-70 years.
- Patients with Hypovolemic shock due to blood loss admitted to the emergency room or ICU with systolic blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment (endotracheal intubation; fluid resuscitation and vasopressors). Standard of care to be provided to the patients shall be the one used in the particular hospital setup.
- Body weight 45 kg - 85 kg.
- Female subject is either: (1) Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or, (2) If of childbearing potential, agrees to use any of the following effective separate forms of contraception throughout the study, up to and including the follow-up visits: Condoms, sponge, foams, jellies, diaphragm or intrauterine device, or A vasectomised partner OR abstinence.
Exclusion
- Terminal illness
- Development of any other terminal illness not associated with Hypovolemic shock due to blood loss during the 28 day observation period
- Patient with severe brain injury or with a Glasgow Coma Scale (GCS) \< 8
- Type of injury is not known
- Inability to obtain intravenous access
- Known pregnancy
- Cardiopulmonary resuscitation (CPR) before randomization
- Presence of a do not resuscitate order
- Patient taking beta adrenergic antagonists
- Untreated tension pneumothorax
- Untreated cardiac tamponade
- Bilateral absent pupillary light reflex (both pupils fixed and dilated)
- 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 :
May 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04056065
Start Date
May 29 2017
End Date
October 21 2018
Last Update
August 14 2019
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Seven Star Hospital
Nagpur, Maha, India
2
KLE's Dr. Prabhakar Kore Hospital & Medical Research Centre
Belagavi, India, 590010
3
Post Graduate Institute of Medical Education and Research
Chandigarh, India, 160012
4
Institute of Postgraduate Medical Education & Research and SSKM Hospital
Kolkata, India, 700020