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A multicentric, randomized, controlled phase III study of centhaquine (Lyfaquin®) as a resuscitative agent in hypovolemic shock patients.

Authors
  • Gulati, Anil
  • Choudhuri, Rajat
  • Gupta, Ajay
  • Singh, Saurabh
  • Noushad Ali, S K
  • Sidhu, Gursaran Kaur
  • Haque, Parvez David
  • Rahate, Prashant
  • Bothra, Aditya R
  • Singh, G P
  • Maheshwari, Sanjeev
  • Jeswani, Deepak
  • Haveri, Sameer
  • Agarwal, Apurva
  • Agrawal, Nilesh Radheshyam
Type
Published Article
Journal
medRxiv : the preprint server for health sciences
Publication Date
Nov 05, 2020
Identifiers
DOI: 10.1101/2020.07.30.20068114
PMID: 33173916
Source
Medline
Language
English
License
Unknown

Abstract

Centhaquine is a novel, first-in-class resuscitative agent for the treatment of hypovolemic shock. Efficacy of centhaquine for the treatment of hypovolemic shock as an adjuvant to standard of care (SOC) was evaluated in a prospective, multi-center, randomized, double-blind, controlled phase III study. Key inclusion criteria were, systolic blood pressure (SBP) of ≤90 mm Hg, blood lactate levels of ≥2 mmol/L and patients receiving SOC in a hospital or ICU setting. Primary endpoints of the study were change in SBP, diastolic blood pressure (DBP), blood lactate levels and base deficit. Mortality through day 28 was the key secondary endpoint. A total of 197 patients were screened, of which 105 patients met eligibility criteria and were included in the study. Patients were randomized in a 2:1 ratio, 71 patients to centhaquine (0.01 mg/kg, IV infusion) group and 34 patients to control group. SOC was provided to both centhaquine and control groups. Demographics were similar in both groups, except patients in saline group were few years younger. Difference between the mean in control and centhaquine groups of hemoglobin level was 0.769 ± 0.590 (P=0.0984) and in hematocrit level was 2.419 ± 1.899 (P=0.1036) at the time of inclusion. Centhaquine substantially reduced 28-day all-cause mortality. In control group, mortality rate was 11.76% compared to 2.94% in centhaquine group (odds ratio: 4.4; 95% CI 0.9651 to 23.74 and P=0.037). At 24 hours of resuscitation, SBP of more than 110 mmHg was in 60.61% patients of control and 79.69% patients of centhaquine group (P=0.0222; OR=2.55); while DBP of more than 70 mmHg was in 51.52% patients of control and 76.56% patients of centhaquine group (P=0.0061; OR=3.075). The number of patients with blood lactate levels of 1.5 mmol/L or less were 46.88% in control group compared to 69.35% in centhaquine group (P=0.0168; OR=2.565). The number of patients with base-deficit of less than minus 2 were 43.75% in control group compared to 69.84% in centhaquine group (P=0.0069; OR=2.977). Shock index improved in centhaquine but not in control group in the first 6 hours of resuscitation. Centhaquine improved acute respiratory distress syndrome (ARDS) and multiple organ dysfunction score (MODS). No drug related adverse event was reported. Centhaquine (Lyfaquin®) is a highly efficacious resuscitative agent for the treatment of hypovolemic shock as an adjuvant to SOC.

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