Health TrialsbyHealthPanel

A Study to Assess the Safety and Efficacy of Centhaquine in Hypovolemic Shock Patients

ConditionHypovolemic Shock
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorPharmazz, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Centhaquine

    Drug

    Centhaquine (LYFAQUIN™ or centhaquine citrate) is a novel, first-in-class, highly effective resuscitative agent for hypovolemic shock. Phase II results demonstrate highly significant efficacy in improving blood pressure (p\<0.0001), lactate levels (p=0.0012) and base-deficit (p\<0.0001). There was also improvement in reduction in use of vasopressors and reduced mortality. Similarly, results of phase III study confirmed the safety and efficacy of centhaquine as an adjuvant to standard of care for hypovolemic shock. Therefore, to assess safety of centhaquine in large population a phase IV study (post-authorization safety study) has been designed.

Treatment groups

400 Participants
are divided into 1 treatment group
Group A: Centhaquine (Dose: 0.01 mg/kg) + Standard of careExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)

Any unfavorable sign, symptom, or disease that occurs while using centhaquine will be reported as an adverse event (AE), including worsening of pre-existing medical conditions. A severe medical occurrence, such as death, life-threatening situations, hospitalization, significant disability, or congenital anomalies will be reported as a serious adverse event (SAE). AEs will be collected through patient questioning, spontaneous reports, and observation. Description, severity, start and end dates, incidence, relationship to the centhaquine, seriousness, action taken, and outcome of AEs will be documented in source documents and case report forms (CRFs). All SAEs will be reported within 24 hours to the sponsor, Drugs Controller General of India, and the ethics committee. Follow-up information and hospitalization or autopsy reports will be provided if necessary. A detailed analyzed report of all SAEs will be prepared and submitted to relevant authorities within 14 days.

Time frame
Up to 7 days

Secondary outcomes

1

Systolic and diastolic blood pressure

Hypovolemia is known to cause low blood pressure, severely. That may lead to multi-organ failure or death. Hence, improving blood pressure is the key to the development of effective hypovolemic shock therapeutics.

Time frame
Up to 7 days
2

Blood lactate

Increased blood lactate level is indicative of hypovolemic shock. Lactate level of more than 2 mmol/L is correlated with increased tissue hypoxia and anaerobic respiration following shock.

Time frame
48 hours
3

Base-deficit

The base deficit is a known measure of metabolic acidosis and has been advocated as a marker of resuscitation adequacy. It is correlated with the severity of injury and degree of hemorrhage, which makes it useful in the operating room (OR) as an endpoint of resuscitation.

Time frame
48 hours
4

Time in intensive care unit (ICU)

In the intensive care unit, specific medical specialties will be provided to support the shock patients whose lives are in immediate danger. ICU medical interventions take over the function of defective or damaged organs and maintain blood pressure in shock patients.

Time frame
Up to 7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pharmazz, Inc.

Lead sponsor

Source ClinicalTrials.gov
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