A randomized, double-blind, placebo-controlled pilot study to evaluate the effect of centhaquine on cardiovascular parameters in patients with hypovolemic shock.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled pilot study to evaluate the effect of centhaquine on cardiovascular parameters in patients with hypovolemic shock.After obtaining institutional ethics committee clearance and written informed consent, patients fulfilling the eligibility criteria will be enrolled in the study.20 eligible patients diagnosed with hypovolemic shock with systolic arterial blood pressure ≤ 90 mmHg at presentation, will be allotted into two groups of 10 each and randomly assigned in 1:1 ratio to receive either centhaquine 0.003mg/kg (Group 1) or placebo (Group 2). They will be treated for a total of 24 hours. 3 doses of 0.003mg/kg centhaquine or placebo at 4 hours of intervals along with standard of care (SOC) will be administered. • Group 1: Centhaquine (Dose: 0.003 mg/kg x 3 doses per day) + Standard of care• Group 2: Placebo (Dose: equal volume saline) + Standard of careIn both treatment groups, subjects will be provided with standard of care. Centhaquine or placebo will be administered intravenously after randomization to hypovolemic shock subjects with systolic arterial blood pressure ≤ 90 mmHg at presentation and continue to receive standard treatment of shock. In the centhaquine group, three doses of centhaquine (0.003 mg/kg) at 4 hours of intervals will be administered as an intravenous infusion over 1 hour in 100 mL normal saline. Placebo group will be administered equal volume of normal saline as an intravenous (IV) infusion over 1 hour. Condition of administration will remain same as for centhaquine group. All subjects will be closely monitored during and after infusion. Vital signs will be monitored every 10 minutes during infusion. In the event of worsening hemodynamics or respiratory status, the infusion will be discontinued. Each subject will also be monitored closely throughout his/her hospitalization and will be followed until discharge from randomization. Each subject will be assessed for cardiovascular parameters such as blood pressure, heart rate, cardiac output, mean arterial pressure and stroke volume. Adverse events will be monitored for safety parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢ Adult males or females aged 18 years or older.
- •â€¢ Subjects with hypovolemic shock admitted to the hospital with systolic blood pressure ≤ 90 mmHg at presentation and continue to receive standard treatment of shock (endotracheal intubation; fluid resuscitation, and vasopressors).
- •The best available standard of care to be provided to the subject.
- •â€¢ Blood lactate level indicative of hypovolemic shock with lactate level more than 2 mmol/L.
- •â€¢ Informed consent provided by the patient or legally authorised representative of the patient.
排除标准
- •Subject with illness clinically defined as septic shock (confirmed or suspected acute infection), cardiogenic shock, neurogenic shock.
- •2.Subject for whom an etiology for hypovolemic shock cannot be determined on initial evaluation.
- •Hypovolemic shock due to traumatic brain injury including any significant CNS injury, traumatic tamponade, traumatic tension pneumothorax, ventricular wall rupture.
- •Patient with altered consciousness not due to hypovolemic shock.
- •Subject with confirmed pregnancy.
- •Cardiopulmonary resuscitation (CPR) before randomization.
- •Presence of a do not resuscitate order.
- •Patient is participating in another interventional study.
- •Patients with a history of systemic disease (chronic renal failure, liver failure, decompensated heart failure) or any terminal illness.
结局指标
主要结局
Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP)
时间窗: Time frame: 24 hours
次要结局
- Change in Stroke Volume (SV)(Before and 1h after each IP)
- Change in cardiac output (CO)(Before and 1h after each IP)
- Proportion of patients with an increase in Mean Arterial Pressure (MAP)(from baseline of at least 10 mmHg)
- Change in Mean Arterial Pressure (MAP)(Mean through 24 hours)
- Change in Heart Rate (HR)(Mean through 24 hours)
- Change in blood lactate(Mean through 24 hours)
- Amount of fluid (crystalloids and colloids) infused(Mean through 24 hours)
- Amounts of vasopressor(s) infused(Mean through 24 hours)
- Total Urine output(Time frame: 24 Hours])
- Proportion of patients with adverse events (AEs) and serious adverse events (SAEs)(Through out study period)