CTRI/2024/05/067244尚未招募3 期
The SODa-BIC RCTSODium BICarbonate for Metabolic Acidosis in the Intensive Care Unit (SODa-BIC): A multicentre, randomised, double-blind clinical trial - SODa-BIC RCT
Dr Ary Serpa Neto0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •All the diagnostic criteria of metabolic acidosis below have to be fulfilled within the last 2 hours before randomisation (pH, PaCO2 and BE from the same blood gas), and a vasopressor is being infused continuously at the time of randomization.
- •Inclusion criteria
- •1Adults more than 18 years
- •2 Receiving a continuous infusion of a vasopressor to maintain mean arterial pressure above 65 mmHg (or a mean arterial pressure target set by the treating clinician)
- •3A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour)and
- •4Metabolic acidosis, defined as
- •1pH less than 7.30 and
- •2BE less than or equal to -4 mEq/L and
- •3PaCO2 less than 45 mmHg.
排除标准
- •Fulfilled all eligibility criteria greater than 48 hours ago or
- •2 Suspected clinically significant digestive or urinary tract loss of sodium bicarbonate ex diarrhoea, ileostomy losses, renal tubular acidosis, or drainage of pancreatic or bile duct) or
- •4 Estimated glomerular filtration rate (eGFR) less than 30 mL/min due to chronic kidney disease or
- •5 Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed) or
- •6 Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team) or
- •7 Severe dysnatraemia (serum Na above 155 mEq/L or below 120 mEq/L)or
- •8 Hypokalaemia (serum K below 2.5 mEq/L) or
- •9 Pulmonary oedema with PaO2 / FiO2 less than 100 or
- •10 Hypocalcaemia (iCa less than 0.8mmol/L)or
- •11 Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication)or
- •12 Pregnancy or breastfeeding or
- •13 Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment or
- •14 Patients with a life expectancy less than 30 days due to a chronic or underlying medical condition or
- •15 Considered to be at high risk of cerebral oedema by the treating clinician (traumatic brain injury or acute brain disease) or
- •16 Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient or
- •17 Previous enrolment in this study
研究者
相似试验
终止
2 期
SODium BICarbonate for metabolic acidosis in the Intensive Care Unit: A pilot, multicentre, randomized, double-blind clinical trialMetabolic acidosisMetabolic and Endocrine - Other metabolic disordersEmergency medicine - Other emergency careACTRN12620001361998Australian and New Zealand Intensive Care Research Centre30
已完成
不适用
A competitive acetate-free bicarbonate dialysate and standard bicarbonate dialysate of iron metabolism dysregulation improvement and cytokine production chilling of hemodialysis patients : a cross-over multicenter study.JPRN-UMIN000000773Hyogo College of Medicine30
进行中（未招募）
3 期
SODium BICarbonate for Metabolic Acidosis in the ICUMetabolic AcidosisShockNCT05697770Australian and New Zealand Intensive Care Research Centre500
招募中
不适用
The evaluations of glucose metabolism, bone metabolism, vascular endothelial function and lipid metabolism by the hormone which regulates circadian rhythm in type 2 diabetes.JPRN-UMIN000019018niversity of Occupational and Environmental Health, Japan, First Department of Internal Medicine, School of Medicine168
已完成
不适用
Correction of metabolic acidosis in continuous ambulatory peritoneal dialysis patients with borderline dialysis adequacy - effect on nutritional status, systemic inflammatory response and patient morbidityISRCTN35726272Hong Kong Health Services Research Fund (Hong Kong)60