Hypovolemic ShockPhase 3NCT05251181
A Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent
A Phase 3 study testing Normal Saline and Centhaquine in people with Hypovolemic Shock, run by Pharmazz, Inc..
Trial summary
This protocol is designed to develop a novel first-in-class treatment for use in critical care and life-threatening condition of hypovolemic shock with unmet need and is of national interest. Shock is a life-threatening condition of circulatory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypovolemic Shock
- What is being tested?
- Normal Saline and Centhaquine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be eligible for inclusion in the study if he/she fulfils the following criteria:
- Adult males or females aged 18 years or older.
- Subjects with hypovolemic shock admitted to the hospital with systolic blood pressure ≤ 90 mm Hg at presentation, Mean Arterial Pressor (MAP) ≤ 65 mm Hg and continue to receive standard treatment of shock (endotracheal intubation; fluid resuscitation and vasopressors). Standard of care to be provided to the subject shall be the one used in that hospital.
- Blood lactate level indicative of hypovolemic shock with lactate level more than 2 mmol/L.
Who cannot join
- A subject will not be eligible for inclusion in this study if he/she meets any of the following exclusion criteria:
- Subject with illness clinically defined as septic shock (Procalcitonin plasma levels of ≥0.5 ng/mL) or cardiogenic shock or neurogenic shock.
- Subject for whom an etiology for hypovolemic shock cannot be determined on initial evaluation.
- Hypovolemic shock due to traumatic brain injury, traumatic tamponade, traumatic tension pneumothorax, ventricular wall rupture.
- Patient with altered consciousness not due to hypovolemic shock.
- Subject with confirmed pregnancy.
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-Centric, Randomized, Double-Blind, Placebo-controlled, Phase-III Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent to be Used as an Adjuvant to Standard Treatment of Hypovolemic Shock
This protocol is designed to develop a novel first-in-class treatment for use in critical care and life-threatening condition of hypovolemic shock with unmet need and is of national interest. Shock is a life-threatening condition of circulatory failure. It is a state of cellular and tissue hypoxia due to reduced oxygen delivery and/or increased oxygen consumption or inadequate oxygen utilization. Shock most commonly occurs when there is circulatory failure leading to reduced tissue perfusion. There are four types of shock: distributive, cardiogenic, hypovolemic, and obstructive. However, these are not exclusive, and many patients with circulatory failure have a combination of more than one form of shock (multifactorial shock).
Read the detailed description
Despite advances in medical science, treatments for hypovolemic shock have changed little in the past 30-40 years. A wounded soldier bleeding on the battlefield, or a trauma victim, is treated today largely as the patient would have been treated in 1970. The primary goal when treating traumatic hemorrhage is to control blood loss, support ventilation and oxygenation, and maintain cardiovascular function to preserve organ blood perfusion. Rapid volume repletion is indicated in patients with severe hypovolemic shock. Delayed therapy can lead to ischemic injury and possibly to irreversible shock and multiorgan system failure. Although resuscitation with intravenous fluids and blood products has remained the gold standard over the last twenty years, vigorous volume resuscitation may not be curative and has been associated with the development of serious complications including coagulopathy, acute lung injury, and abdominal compartment syndrome. Massive resuscitation also profoundly alters the neuroendocrine milieu needed to maintain vasomotor tone and may lead to a state of recalcitrant hypotension, multi-organ failure, and ultimately death in severely injured patients. Vasopressors are generally used to increase blood pressure and cardiac output, but sometimes they are not recommended since they do not correct the primary problem and tend to reduce tissue perfusion further.
This study seeks to address the impact of centhaquine on the patient population with hypovolemic shock (prehospital SBP ≤ 90 mmHg). The inclusion of centhaquine during resuscitation could potentially prevent the profound hypotension seen in late-stage shock, limit the need for aggressive volume and blood product resuscitation, and decrease the incidence of resuscitation-associated complications. This study will investigate if early use of centhaquine during the resuscitation of hypovolemic shock results in improved survival at Day 28, fewer blood transfusions, a decreased need for crystalloid resuscitation, and a lower incidence of resuscitation related complications.
In animal models of hypovolemic shock, low doses (0.006 to 0.05 mg/kg) of centhaquine proved to be highly effective in resuscitation. Centhaquine significantly decreased blood lactate and increased mean arterial pressure (MAP), pulse pressure, and cardiac output (CO), as well as decreased mortality and increased the survival time of animals with severe blood loss. Furthermore, its resuscitative effect was significantly greater compared to presently used resuscitative solutions. The proposed mechanism of action of centhaquine is that in low doses, it acts on α2B adrenergic receptors to produce venous constriction and a consequent increase in venous return to the heart, and stimulation of sodium sense in the brain to increase the intravascular blood volume. These effects increase cardiac output and tissue blood perfusion, which may be responsible for its resuscitative action.
Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. Its safety and tolerability have been demonstrated in a human phase I study in 25 subjects. Clinical phase II and III results indicate that centhaquine is a novel first-in-class, highly effective resuscitative agent for hypovolemic shock due to blood loss. Safety and highly significant efficacy in improving blood pressure, lactate levels, base deficit, and reduction in the use of vasopressors and reduced mortality obtained in phase II and III studies in patients of hypovolemic shock are convincing. Therefore, a phase III clinical study in the United States and Europe will be conducted in patients of hypovolemic shock patients.
The present multi-centric, randomized, double-blind, placebo-controlled phase-III study aims to assess the efficacy and safety of centhaquine as a resuscitative agent to be used as an adjuvant to standard treatment of hypovolemic shock.
- Conditions
- Hypovolemic Shock
- Being tested
- Normal Saline, Centhaquine
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
Also called Vehicle
Normal Saline to be Used as Vehicle in the Phase-III Study to Assess Efficacy of Centhaquine as a Resuscitative Agent for Hypovolemic Shock
CenthaquineDrug
Also called PMZ-2010
Phase-III Study to Assess Efficacy of Centhaquine as a Resuscitative Agent for Hypovolemic Shock
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Active comparator | Hypovolemic shock patients will be provided the standard of care. Following randomization 100 ml (equal volume to experimental arm) of normal saline will be administered intravenously over 1 hour. Receives: Drug: Normal Saline |
| Centhaquine | Experimental | Hypovolemic shock patients will be provided the standard of care. Following randomization centhaquine (0.01 mg/kg) will be administered intravenously over 1 hour in 100 mL of normal saline. Receives: Drug: Centhaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with all-cause mortality [Time frame: Day 0 through day 28].
Incidence of mortality
Measured: Day 0 through day 28
Secondary outcomes (4)
Proportion of subjects with all-cause mortality within 48 hours
Proportion of subjects with all-cause mortality within 48 hours
Measured: 48 hours
Change in Mean Arterial Pressure (MAP) from baseline of at least 10 mm Hg; Mean through 48 hours and at the time of discharge or day 7
Change in Mean Arterial Pressure (MAP) from baseline of at least 10 mm Hg; Mean through 48 hours and at the time of discharge or day 7
Measured: First 48 hours and at the time of discharge or day 7
Time (hours) to decrease blood lactate level to <2 mmol/L
Time (hours) to decrease blood lactate level to <2 mmol/L; Mean through 2 hours for the first 12 hours, then every 6 hours for the next 36 hours.
Measured: 48 hours
Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
Measured: Day 0 through day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study startFeb 2027 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Hypovolemic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-centric, randomized, double-blind, placebo-controlled phase-III clinical study to assess the safety and efficacy of centhaquine therapy in patients with hypovolemic shock with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard treatment of shock. This protocol is designed to develop a novel first-in-class treatment for use in critical care and life-threatening condition of hypovolemic shock with unmet need and is of national interest.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmazz, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251181
- Sponsor's protocol ID
- Centhaquine/CT-3.2/2021
- Status last verified
- Dec 2025
- First submitted
- 11 Feb 2022
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Geevarghese M 3rd, Patel K, Gulati A, Ranjan AK. Role of adrenergic receptors in shock. Front Physiol. 2023 Jan 16;14:1094591. doi: 10.3389/fphys.2023.1094591. eCollection 2023.
PubMed 36726848Ranjan AK, Gulati A. Controls of Central and Peripheral Blood Pressure and Hemorrhagic/Hypovolemic Shock. J Clin Med. 2023 Jan 31;12(3):1108. doi: 10.3390/jcm12031108.
PubMed 36769755Chalkias A, Pais G, Gulati A. Effect of Centhaquine on the Coagulation Cascade in Normal State and Uncontrolled Hemorrhage: A Multiphase Study Combining Ex Vivo and In Vivo Experiments in Different Species. Int J Mol Sci. 2024 Mar 20;25(6):3494. doi: 10.3390/ijms25063494.
PubMed 38542464Khanna A, Vaidya K, Shah D, Ranjan AK, Gulati A. Centhaquine Increases Stroke Volume and Cardiac Output in Patients with Hypovolemic Shock. J Clin Med. 2024 Jun 27;13(13):3765. doi: 10.3390/jcm13133765.
PubMed 38999331Gulati A, Choudhuri R, Gupta A, Singh S, Ali SKN, Sidhu GK, Haque PD, Rahate P, Bothra AR, Singh GP, Maheshwari S, Jeswani D, Haveri S, Agarwal A, Agrawal NR. A Multicentric, Randomized, Controlled Phase III Study of Centhaquine (Lyfaquin(R)) as a Resuscitative Agent in Hypovolemic Shock Patients. Drugs. 2021 Jun;81(9):1079-1100. doi: 10.1007/s40265-021-01547-5. Epub 2021 Jun 1.
PubMed 34061314Gulati A, Jain D, Agrawal NR, Rahate P, Choudhuri R, Das S, Dhibar DP, Prabhu M, Haveri S, Agarwal R, Lavhale MS. Resuscitative Effect of Centhaquine (Lyfaquin(R)) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial. Adv Ther. 2021 Jun;38(6):3223-3265. doi: 10.1007/s12325-021-01760-4. Epub 2021 May 10.
PubMed 33970455Kontouli Z, Staikou C, Iacovidou N, Mamais I, Kouskouni E, Papalois A, Papapanagiotou P, Gulati A, Chalkias A, Xanthos T. Resuscitation with centhaquin and 6% hydroxyethyl starch 130/0.4 improves survival in a swine model of hemorrhagic shock: a randomized experimental study. Eur J Trauma Emerg Surg. 2019 Dec;45(6):1077-1085. doi: 10.1007/s00068-018-0980-1. Epub 2018 Jul 13.
PubMed 30006694Ranjan AK, Zhang Z, Briyal S, Gulati A. Centhaquine Restores Renal Blood Flow and Protects Tissue Damage After Hemorrhagic Shock and Renal Ischemia. Front Pharmacol. 2021 May 3;12:616253. doi: 10.3389/fphar.2021.616253. eCollection 2021.
PubMed 34012389Papalexopoulou K, Chalkias A, Pliatsika P, Papalois A, Papapanagiotou P, Papadopoulos G, Arnaoutoglou E, Petrou A, Gulati A, Xanthos T. Centhaquin Effects in a Swine Model of Ventricular Fibrillation: Centhaquin and Cardiac Arrest. Heart Lung Circ. 2017 Aug;26(8):856-863. doi: 10.1016/j.hlc.2016.11.008. Epub 2016 Dec 19.
PubMed 28385449O'Donnell JN, O'Donnell EP, Kumar EJ, Lavhale MS, Andurkar SV, Gulati A, Scheetz MH. Pharmacokinetics of centhaquin citrate in a dog model. J Pharm Pharmacol. 2016 Jun;68(6):803-9. doi: 10.1111/jphp.12554. Epub 2016 Apr 25.
PubMed 27109141O'Donnell JN, Gulati A, Lavhale MS, Sharma SS, Patel AJ, Rhodes NJ, Scheetz MH. Pharmacokinetics of centhaquin citrate in a rat model. J Pharm Pharmacol. 2016 Jan;68(1):56-62. doi: 10.1111/jphp.12498. Epub 2016 Jan 4.
PubMed 26725913Papapanagiotou P, Xanthos T, Gulati A, Chalkias A, Papalois A, Kontouli Z, Alegakis A, Iacovidou N. Centhaquin improves survival in a swine model of hemorrhagic shock. J Surg Res. 2016 Jan;200(1):227-35. doi: 10.1016/j.jss.2015.06.056. Epub 2015 Jun 29.
PubMed 26216751Gulati A, Zhang Z, Murphy A, Lavhale MS. Efficacy of centhaquin as a small volume resuscitative agent in severely hemorrhaged rats. Am J Emerg Med. 2013 Sep;31(9):1315-21. doi: 10.1016/j.ajem.2013.05.032. Epub 2013 Jul 19.
PubMed 23871440Lavhale MS, Havalad S, Gulati A. Resuscitative effect of centhaquin after hemorrhagic shock in rats. J Surg Res. 2013 Jan;179(1):115-24. doi: 10.1016/j.jss.2012.08.042. Epub 2012 Sep 2.
PubMed 22964270Gulati A, Lavhale MS, Garcia DJ, Havalad S. Centhaquin improves resuscitative effect of hypertonic saline in hemorrhaged rats. J Surg Res. 2012 Nov;178(1):415-23. doi: 10.1016/j.jss.2012.02.005. Epub 2012 Apr 2.
PubMed 22487389
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centric, Randomized, Double-Blind, Placebo-controlled, Phase-III Study to Assess Safety and Efficacy of Centhaquine as a Resuscitative Agent to be Used as an Adjuvant to Standard Treatment of Hypovolemic Shock
- ClinicalTrials.gov ID
- NCT05251181
- Acronym / sponsor ID
- Centhaquine/CT-3.2/2021
- Conditions
- Hypovolemic Shock
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Pharmazz, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol is designed to develop a novel first-in-class treatment for use in critical care and life-threatening condition of hypovolemic shock with unmet need and is of national interest. Shock is a life-threatening condition of circulatory failure. It is a state of cellular and tissue hypoxia due to reduced oxygen delivery and/or increased oxygen consumption or inadequate oxygen utilization. Shock most commonly occurs when there is circulatory failure leading to reduced tissue perfusion. There are four types of shock: distributive, cardiogenic, hypovolemic, and obstructive. However, these are not exclusive, and many patients with circulatory failure have a combination of more than one form of shock (multifactorial shock).
Detailed description
Despite advances in medical science, treatments for hypovolemic shock have changed little in the past 30-40 years. A wounded soldier bleeding on the battlefield, or a trauma victim, is treated today largely as the patient would have been treated in 1970. The primary goal when treating traumatic hemorrhage is to control blood loss, support ventilation and oxygenation, and maintain cardiovascular function to preserve organ blood perfusion. Rapid volume repletion is indicated in patients with severe hypovolemic shock. Delayed therapy can lead to ischemic injury and possibly to irreversible shock and multiorgan system failure. Although resuscitation with intravenous fluids and blood products has remained the gold standard over the last twenty years, vigorous volume resuscitation may not be curative and has been associated with the development of serious complications including coagulopathy, acute lung injury, and abdominal compartment syndrome. Massive resuscitation also profoundly alters the neuroendocrine milieu needed to maintain vasomotor tone and may lead to a state of recalcitrant hypotension, multi-organ failure, and ultimately death in severely injured patients. Vasopressors are generally used to increase blood pressure and cardiac output, but sometimes they are not recommended since they do not correct the primary problem and tend to reduce tissue perfusion further.
This study seeks to address the impact of centhaquine on the patient population with hypovolemic shock (prehospital SBP ≤ 90 mmHg). The inclusion of centhaquine during resuscitation could potentially prevent the profound hypotension seen in late-stage shock, limit the need for aggressive volume and blood product resuscitation, and decrease the incidence of resuscitation-associated complications. This study will investigate if early use of centhaquine during the resuscitation of hypovolemic shock results in improved survival at Day 28, fewer blood transfusions, a decreased need for crystalloid resuscitation, and a lower incidence of resuscitation related complications.
In animal models of hypovolemic shock, low doses (0.006 to 0.05 mg/kg) of centhaquine proved to be highly effective in resuscitation. Centhaquine significantly decreased blood lactate and increased mean arterial pressure (MAP), pulse pressure, and cardiac output (CO), as well as decreased mortality and increased the survival time of animals with severe blood loss. Furthermore, its resuscitative effect was significantly greater compared to presently used resuscitative solutions. The proposed mechanism of action of centhaquine is that in low doses, it acts on α2B adrenergic receptors to produce venous constriction and a consequent increase in venous return to the heart, and stimulation of sodium sense in the brain to increase the intravascular blood volume. These effects increase cardiac output and tissue blood perfusion, which may be responsible for its resuscitative action.
Centhaquine has been found to be an effective resuscitative agent in rat, rabbit, and swine models of hemorrhagic shock. Its safety and tolerability have been demonstrated in a human phase I study in 25 subjects. Clinical phase II and III results indicate that centhaquine is a novel first-in-class, highly effective resuscitative agent for hypovolemic shock due to blood loss. Safety and highly significant efficacy in improving blood pressure, lactate levels, base deficit, and reduction in the use of vasopressors and reduced mortality obtained in phase II and III studies in patients of hypovolemic shock are convincing. Therefore, a phase III clinical study in the United States and Europe will be conducted in patients of hypovolemic shock patients.
The present multi-centric, randomized, double-blind, placebo-controlled phase-III study aims to assess the efficacy and safety of centhaquine as a resuscitative agent to be used as an adjuvant to standard treatment of hypovolemic shock.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multi-centric, randomized, double-blind, placebo-controlled phase-III clinical study to assess the safety and efficacy of centhaquine therapy in patients with hypovolemic shock with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard treatment of shock. This protocol is designed to develop a novel first-in-class treatment for use in critical care and life-threatening condition of hypovolemic shock with unmet need and is of national interest.
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Active comparator | Drug: Normal SalineHypovolemic shock patients will be provided the standard of care. Following randomization 100 ml (equal volume to experimental arm) of normal saline will be administered intravenously over 1 hour. |
| Centhaquine | Experimental | Drug: CenthaquineHypovolemic shock patients will be provided the standard of care. Following randomization centhaquine (0.01 mg/kg) will be administered intravenously over 1 hour in 100 mL of normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A subject will be eligible for inclusion in the study if he/she fulfils the following criteria:
- Adult males or females aged 18 years or older.
- Subjects with hypovolemic shock admitted to the hospital with systolic blood pressure ≤ 90 mm Hg at presentation, Mean Arterial Pressor (MAP) ≤ 65 mm Hg and continue to receive standard treatment of shock (endotracheal intubation; fluid resuscitation and vasopressors). Standard of care to be provided to the subject shall be the one used in that hospital.
- Blood lactate level indicative of hypovolemic shock with lactate level more than 2 mmol/L.
Key exclusion criteria (10 listed)
- A subject will not be eligible for inclusion in this study if he/she meets any of the following exclusion criteria:
- Subject with illness clinically defined as septic shock (Procalcitonin plasma levels of ≥0.5 ng/mL) or cardiogenic shock or neurogenic shock.
- Subject for whom an etiology for hypovolemic shock cannot be determined on initial evaluation.
- Hypovolemic shock due to traumatic brain injury, traumatic tamponade, traumatic tension pneumothorax, ventricular wall rupture.
- Patient with altered consciousness not due to hypovolemic shock.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal SalineAlso: VehicleNormal Saline to be Used as Vehicle in the Phase-III Study to Assess Efficacy of Centhaquine as a Resuscitative Agent for Hypovolemic Shock | Drug | Normal saline |
| CenthaquineAlso: PMZ-2010Phase-III Study to Assess Efficacy of Centhaquine as a Resuscitative Agent for Hypovolemic Shock | Drug | Centhaquine |
Primary outcome
Proportion of subjects with all-cause mortality [Time frame: Day 0 through day 28].
Time frame: Day 0 through day 28
Incidence of mortality
4 secondary outcomes
Proportion of subjects with all-cause mortality within 48 hours
Time frame: 48 hours
Change in Mean Arterial Pressure (MAP) from baseline of at least 10 mm Hg; Mean through 48 hours and at the time of discharge or day 7
Time frame: First 48 hours and at the time of discharge or day 7
Time (hours) to decrease blood lactate level to <2 mmol/L
Time frame: 48 hours
Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day 0 through day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 36726848Geevarghese M 3rd, Patel K, Gulati A, Ranjan AK. Role of adrenergic receptors in shock. Front Physiol. 2023 Jan 16;14:1094591. doi: 10.3389/fphys.2023.1094591. eCollection 2023.
- Background: PubMed 36769755Ranjan AK, Gulati A. Controls of Central and Peripheral Blood Pressure and Hemorrhagic/Hypovolemic Shock. J Clin Med. 2023 Jan 31;12(3):1108. doi: 10.3390/jcm12031108.
- Background: PubMed 38542464Chalkias A, Pais G, Gulati A. Effect of Centhaquine on the Coagulation Cascade in Normal State and Uncontrolled Hemorrhage: A Multiphase Study Combining Ex Vivo and In Vivo Experiments in Different Species. Int J Mol Sci. 2024 Mar 20;25(6):3494. doi: 10.3390/ijms25063494.
- Background: PubMed 38999331Khanna A, Vaidya K, Shah D, Ranjan AK, Gulati A. Centhaquine Increases Stroke Volume and Cardiac Output in Patients with Hypovolemic Shock. J Clin Med. 2024 Jun 27;13(13):3765. doi: 10.3390/jcm13133765.
- Background: PubMed 34061314Gulati A, Choudhuri R, Gupta A, Singh S, Ali SKN, Sidhu GK, Haque PD, Rahate P, Bothra AR, Singh GP, Maheshwari S, Jeswani D, Haveri S, Agarwal A, Agrawal NR. A Multicentric, Randomized, Controlled Phase III Study of Centhaquine (Lyfaquin(R)) as a Resuscitative Agent in Hypovolemic Shock Patients. Drugs. 2021 Jun;81(9):1079-1100. doi: 10.1007/s40265-021-01547-5. Epub 2021 Jun 1.
- Background: PubMed 33970455Gulati A, Jain D, Agrawal NR, Rahate P, Choudhuri R, Das S, Dhibar DP, Prabhu M, Haveri S, Agarwal R, Lavhale MS. Resuscitative Effect of Centhaquine (Lyfaquin(R)) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial. Adv Ther. 2021 Jun;38(6):3223-3265. doi: 10.1007/s12325-021-01760-4. Epub 2021 May 10.
- Background: PubMed 30006694Kontouli Z, Staikou C, Iacovidou N, Mamais I, Kouskouni E, Papalois A, Papapanagiotou P, Gulati A, Chalkias A, Xanthos T. Resuscitation with centhaquin and 6% hydroxyethyl starch 130/0.4 improves survival in a swine model of hemorrhagic shock: a randomized experimental study. Eur J Trauma Emerg Surg. 2019 Dec;45(6):1077-1085. doi: 10.1007/s00068-018-0980-1. Epub 2018 Jul 13.
- Background: PubMed 34012389Ranjan AK, Zhang Z, Briyal S, Gulati A. Centhaquine Restores Renal Blood Flow and Protects Tissue Damage After Hemorrhagic Shock and Renal Ischemia. Front Pharmacol. 2021 May 3;12:616253. doi: 10.3389/fphar.2021.616253. eCollection 2021.
- Background: PubMed 28385449Papalexopoulou K, Chalkias A, Pliatsika P, Papalois A, Papapanagiotou P, Papadopoulos G, Arnaoutoglou E, Petrou A, Gulati A, Xanthos T. Centhaquin Effects in a Swine Model of Ventricular Fibrillation: Centhaquin and Cardiac Arrest. Heart Lung Circ. 2017 Aug;26(8):856-863. doi: 10.1016/j.hlc.2016.11.008. Epub 2016 Dec 19.
- Background: PubMed 27109141O'Donnell JN, O'Donnell EP, Kumar EJ, Lavhale MS, Andurkar SV, Gulati A, Scheetz MH. Pharmacokinetics of centhaquin citrate in a dog model. J Pharm Pharmacol. 2016 Jun;68(6):803-9. doi: 10.1111/jphp.12554. Epub 2016 Apr 25.
- Background: PubMed 26725913O'Donnell JN, Gulati A, Lavhale MS, Sharma SS, Patel AJ, Rhodes NJ, Scheetz MH. Pharmacokinetics of centhaquin citrate in a rat model. J Pharm Pharmacol. 2016 Jan;68(1):56-62. doi: 10.1111/jphp.12498. Epub 2016 Jan 4.
- Background: PubMed 26216751Papapanagiotou P, Xanthos T, Gulati A, Chalkias A, Papalois A, Kontouli Z, Alegakis A, Iacovidou N. Centhaquin improves survival in a swine model of hemorrhagic shock. J Surg Res. 2016 Jan;200(1):227-35. doi: 10.1016/j.jss.2015.06.056. Epub 2015 Jun 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Normal Saline and Centhaquine in people with Hypovolemic Shock, run by Pharmazz, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anil Gulati, MD, PhD (6307806087, anil.gulati@pharmazz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with all-cause mortality [Time frame: Day 0 through day 28]. (time frame: Day 0 through day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251181, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.