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
Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
This is a prospective, multi-centric, open-labeled, phase-IV clinical study to evaluate the safety and efficacy of centhaquine citrate (LYFAQUIN™), a first-in-class drug for treating hypovolemic shock, a life-threatening condition caused by severe blood or fluid loss. Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. It has demonstrated the ability to decrease blood lactate levels, increase mean arterial pressure, enhance cardiac output, and reduce mortality rates. The increase in cardiac output during resuscitation is primarily attributed to an augmentation in stroke volume. Centhaquine exerts its effects by acting on the venous α2B-adrenergic receptors, which enhances venous return to the heart. Additionally, it produces arterial dilation by targeting central α2A-adrenergic receptors, thereby reducing sympathetic activity and systemic vascular resistance.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• • 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).
Locations
Other Locations
India
Pushpanjali Hospital
RECRUITING
Agra
Sri Guru Ram Das University of Health Sciences (SGRDH)
RECRUITING
Amritsar
KG Hospital
RECRUITING
Coimbatore
Maharani Laxmi Bai Medical College (MLBMC)
RECRUITING
Jhānsi
Nirmal Hospital
RECRUITING
Jhānsi
Ganesh Shankar Vidyarthi Memorial Medical College (GSVM)
RECRUITING
Kanpur
IPGMER & SSKM Hospital
RECRUITING
Kolkata
Government Medical College
RECRUITING
Kota
Christian Medical College and Hospital (CMC)
RECRUITING
Ludhiana
Dayanand Medical College & Hospital (DMCH)
RECRUITING
Ludhiana
Meditrina Hospital
RECRUITING
Nagpur
New Era Hospital
RECRUITING
Nagpur
Seven Star Hospital
RECRUITING
Nagpur
ACSR Government Medical College and Hospital
RECRUITING
Nellore
All India Institute of Medical Sciences (AIIMS)
RECRUITING
Raipur
Aman Hospital
RECRUITING
Vadodara
Janta Hospital
RECRUITING
Varanasi
Contact Information
Primary
Dharmesh Shah, Dr.
dharmesh.shah@pharmazz.com
+91(120)256-9779
Time Frame
Start Date:2021-08-13
Estimated Completion Date:2025-12
Participants
Target number of participants:400
Treatments
Experimental: Centhaquine (Dose: 0.01 mg/kg) + Standard of care
Centhaquine will be administered intravenously after enrollment to hypovolemic shock patients with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard shock treatment. Centhaquine will be administered at a dose of 0.01 mg/kg of body weight, as an intravenous (IV) infusion over 1 hour in 100 mL of normal saline. Second dose of centhaquine will be administered if SBP falls below or remains below or equal to 90 mmHg but not before 4 hours of the previous dose and total doses per day (in 24 hours) will not exceed 3 doses. Centhaquine administration if needed will continue for two days post-enrollment. A minimum of 1 dose or maximum of 6 doses of centhaquine will be administered within first 48 hours post-enrollment. Each patient will be monitored closely throughout his/her hospitalization and will be followed until discharge or day 7 (whichever is earlier) from enrollment.