EUCTR2022-003703-16-IT招募中1 期
The effect of phoSPHocreatine on mEdical emergency team (met) tREated patients: a randomized clinical trial protocol - SPHERE. - SPHERE
OSPEDALE SAN RAFFAELE0 个研究点目标入组 400 人开始时间: 2023年1月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
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
- 性别
- All
入选标准
- •1.Threatened airways;
- •2. Respiratory arrest;
- •3. Respiratory rate <5 or >36 breaths per min;
- •4. Pulse rate <40 or >140 beats per min;
- •5. Systolic blood pressure < 90 mm Hg;
- •6. Sudden fall in level of consciousness;
- •7. Fall in Glasgow coma scale of > 2 points.
- •8. Written informed consent from the patient him-/herself or the patient's next of kin or the legal representative as requested by the ethics committee.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
排除标准
- •Exclusion criteria
- •1.Age < 18 years;
- •2. Ongoing cardiac massage;
- •3. Current hospital admission from a care nursing facility;
- •4. Planned discharge to a care nursing facility;
- •5. Reasons for withdrawal of life-sustaining therapy;
- •6. History of kidney transplantation;
- •7. Solitary kidney (by any reason);
- •8. Serum Creatinine > 2 mg/dl;
- •9. Immediate need for ICU admission;
- •10. Known allergy to PCr;
- •11. Previous enrollment and randomization into this trial;
- •13. Administration of PCr in the previous 30 day.
- •14. Pregnancy
研究者
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