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Resuscitative Effect of Centhaquine (Lyfaquin®) in Hypovolemic Shock Patients: A Randomized, Multicentric, Controlled Trial.
Gulati, Anil; Jain, Dinesh; Agrawal, Nilesh Radheshyam; Rahate, Prashant; Choudhuri, Rajat; Das, Soumen; Dhibar, Deba Prasad; Prabhu, Madhav; Haveri, Sameer; Agarwal, Rohit; Lavhale, Manish S.
  • Gulati A; Professor Emeritus, Midwestern University, Downers Grove, IL, USA. agulati@midestern.edu.
  • Jain D; Department of Medicine, Dayanand Medical College & Hospital, Civil Lines, Tagore Nagar, Ludhiana, Punjab, 141001, India.
  • Agrawal NR; Department of Neurology, New Era Hospital, Near Jalaram Mandir, Queta Colony, Telephone Exchange Chowk, Central Avenue Road, Nagpur, Maharashtra, 440008, India.
  • Rahate P; Seven Star Hospital Jagnade Square, KDK College Road, Nagpur, Maharashtra, 440009, India.
  • Choudhuri R; Department of Anaesthesiology, Institute of Post-Graduate Medical Education and Research and SSKM Hospital, 244 A.J.C. Bose Road, Kolkata, West Bengal, 700020, India.
  • Das S; Department of Surgery, Institute of Post-Graduate Medical Education and Research and SSKM Hospital, 244 A.J.C. Bose Road, Kolkata, West Bengal, 700020, India.
  • Dhibar DP; Department of Internal Medicine, Nehru Hospital, Post-Graduate Institute of Medical Education and Research (PGIMER), Sector-12, Chandigarh, 160 012, India.
  • Prabhu M; Department of Medicine, KLE's Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belgaum, Karnataka, 590010, India.
  • Haveri S; Department of Orthopaedics, KLE's Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belgaum, Karnataka, 590010, India.
  • Agarwal R; Department of Anaesthesiology, ORIANA Hospital, Plot No.: 6, 7, 8 Ravindrapuri Bhelpur, Varanasi, Uttar Pradesh, 221005, India.
  • Lavhale MS; Pharmazz India Private Limited, Greater Noida, India.
Adv Ther ; 38(6): 3223-3265, 2021 06.
Article in English | MEDLINE | ID: covidwho-1279500
ABSTRACT

INTRODUCTION:

Centhaquine (Lyfaquin®) showed significant efficacy as a resuscitative agent in animal models of haemorrhagic shock. Its safety and tolerability were confirmed in healthy human volunteers. In this study, our primary objective was to determine the safety, and the secondary objective was to assess the efficacy of centhaquine in patients with hypovolemic shock.

METHODS:

A prospective, multicentre, randomized phase II study was conducted in male and female patients aged 18-70 years with hypovolemic shock having systolic BP ≤ 90 mmHg. Patients were randomized in a 11 ratio to either the control or centhaquine group. The control group received 100 ml of normal saline infusion over 1 h, while the centhaquine group received 0.01 mg/kg of centhaquine in 100 ml normal saline infusion over 1 h. Every patient received standard of care (SOC) and was followed for 28 days.

RESULTS:

Fifty patients were included, and 45 completed the trial 22 in the control group and 23 in the centhaquine group. The demographics of patients in both groups were comparable. No adverse event related to centhaquine was recorded in the 28-day observation period. The baseline, Injury Scoring System score, haemoglobin, and haematocrit were similar in both groups. However, 91% of the patients in the centhaquine group needed major surgery, whereas only 68% in the control group (p = 0.0526). Twenty-eight-day all-cause mortality was 0/23 in the centhaquine group and 2/22 in the control group. The percent time in ICU and ventilator support was less in the centhaquine group than in the control group. The total amount of vasopressors needed in the first 48 h of resuscitation was lower in the centhaquine group than in the control group (3.12 ± 2.18 vs. 9.39 ± 4.28 mg). An increase in systolic and diastolic BP from baseline through 48 h was more marked in the centhaquine group than in the control group. Compared with the control group, blood lactate level was lower by 1.75 ± 1.07 mmol/l in the centhaquine group on day 3 of resuscitation. Improvements in base deficit, multiple organ dysfunction syndrome (MODS) score and adult respiratory distress syndrome (ARDS) were greater in the centhaquine group than in the control group.

CONCLUSION:

When added to SOC, centhaquine is a well-tolerated and effective resuscitative agent. It improves the clinical outcome of patients with hypovolemic shock. TRIAL REGISTRATION ClinicalTrials.gov identifier number NCT04056065.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Shock / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male Language: English Journal: Adv Ther Journal subject: Therapeutics Year: 2021 Document Type: Article Affiliation country: S12325-021-01760-4

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Shock / COVID-19 Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Limits: Adult / Female / Humans / Male Language: English Journal: Adv Ther Journal subject: Therapeutics Year: 2021 Document Type: Article Affiliation country: S12325-021-01760-4