Assessing Centhaquine for treating hypovolemic shock
A Prospective, Multi-centric, Open-labeled, Phase-IV Study to Assess Safety and Efficacy of LYFAQUIN™ (Centhaquine Citrate) as a Resuscitative Agent for Hypovolemic Shock to be Used as an Adjuvant to Standard Treatment of Shock
This study is testing if a new treatment called centhaquine can help adults with hypovolemic shock feel better and survive longer when used with standard care.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pharmazz, Inc. Industry-sponsored |
| Locations | 17 sites (Nellore, Andhra Pradesh and 16 other locations) |
| Trial ID | NCT05956418 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of centhaquine citrate, a novel treatment for hypovolemic shock, in approximately 400 adult patients. Participants will receive centhaquine alongside standard shock treatment, including fluid resuscitation and vasopressors, while being closely monitored throughout their hospitalization. The study aims to determine if centhaquine can improve blood pressure, reduce lactate levels, and ultimately decrease mortality rates in these patients. The drug works by enhancing venous return to the heart and producing arterial dilation, which may improve cardiac output during resuscitation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with hypovolemic shock and a systolic blood pressure of 90 mmHg or lower upon hospital admission.
Not a fit: Patients with terminal illnesses unrelated to hypovolemic shock, altered consciousness, or those who have undergone CPR prior to enrollment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from hypovolemic shock.
How similar studies have performed: While centhaquine has shown promise in animal models, this study represents a novel approach in human subjects for treating hypovolemic shock.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria • Adult hypovolemic shock patients aged 18 years or older 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 Criteria * Development of any other terminal illness not associated with hypovolemic shock during the study duration. * Patient with altered consciousness not due to hypovolemic shock and comatose patient. • Known pregnancy. * Cardiopulmonary resuscitation (CPR) before enrollment. * 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 sepsis, cancer, chronic renal failure, liver failure, decompensated heart failure, or AIDS.
Where this trial is running
Nellore, Andhra Pradesh and 16 other locations
- ACSR Government Medical College and Hospital — Nellore, Andhra Pradesh, India (Recruiting)
- All India Institute of Medical Sciences (AIIMS) — Raipur, Chhattisgarh, India (Recruiting)
- Aman Hospital — Vadodara, Gujarat, India (Recruiting)
- New Era Hospital — Nagpur, Maharashtra, India (Recruiting)
- Seven Star Hospital — Nagpur, Maharashtra, India (Recruiting)
- Meditrina Hospital — Nagpur, Maharashtra, India (Recruiting)
- Sri Guru Ram Das University of Health Sciences (SGRDH) — Amritsar, Punjab, India (Recruiting)
- Dayanand Medical College & Hospital (DMCH) — Ludhiana, Punjab, India (Recruiting)
- Christian Medical College and Hospital (CMC) — Ludhiana, Punjab, India (Recruiting)
- Government Medical College — Kota, Rajasthan, India (Recruiting)
- KG Hospital — Coimbatore, Tamil Nadu, India (Recruiting)
- Pushpanjali Hospital — Agra, Uttar Pradesh, India (Recruiting)
- Maharani Laxmi Bai Medical College (MLBMC) — Jhānsi, Uttar Pradesh, India (Recruiting)
- Nirmal Hospital — Jhānsi, Uttar Pradesh, India (Recruiting)
- Ganesh Shankar Vidyarthi Memorial Medical College (GSVM) — Kanpur, Uttar Pradesh, India (Recruiting)
- Janta Hospital — Varanasi, Uttar Pradesh, India (Recruiting)
- IPGMER & SSKM Hospital — Kolkata, West Bengal, India (Recruiting)
Study contacts
- Study coordinator: Dharmesh Shah, Dr.
- Email: dharmesh.shah@pharmazz.com
- Phone: +91(120)256-9779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.