CTRI/2023/11/059609尚未招募3 期
Metabolic Resuscitation in Pediatric Septic Shock Using HAT (Hydrocortisone, Ascorbic acid and Thiamine) Therapy an Open Label Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
- •Illness -Admitted to PICU treated for septic shock (fluid refractory shock)
- •Treatment Received inotropes for at least 2 h
- •Consent Parental/caregiver consent prior to or after enrolment
- •(Definitions of surviving sepsis campaign 2020 will be followed for diagnosis of septic shock)
排除标准
- •1.Age Preterm babies born <34 weeks gestation that have a corrected age of <28 days
- •2.Treatment - Received inotropes for >24 h pre-enrolment
- •3.Patient is receiving treatment for a systemic fungal infection or has documented strongyloides infection at the time of randomization
- •4.Patient undergoing active chemotherapy for cancer treatment
- •5.Co-morbidities •Fulmonant Myocarditis, Congenital heart disease
- •6.Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment.
- •7.Known chronic kidney disease (defined as requiring Renal Replacement Therapy)
- •8.Known chronic hepatic failure
- •9.Known diseases affecting the steroid axis, including pituitary disease, congenital adrenal hypoplasia, Cushing or Addison’s
- •10.Known glucose-6 phosphate dehydrogenase (G-6PD) deficiency
- •11.Patients with a known history of oxalate nephropathy
- •12.Patients with acute beriberi disease
- •13.Patients with acute Wernike’s encephalopathy
- •14.Patients with known malaria
- •15.Patients with known suspected scurvy
- •16.Palliative care patient/patient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation, or ventilation)
- •17.Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of >2min duration, or death is deemed to be imminent or inevitable during this admission.
- •18.Major bleeding with hemorrhagic shock
- •19.Sepsis is not likely to be the cause of shock
研究者
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