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临床试验/DRKS00000741
DRKS00000741已完成未知

Sepsis survivors Monitoring and coordination in Outpatient Health care - Smooth

Center for Sepsis Control & Care, Universitätsklinikum Jena0 个研究点目标入组 290 人开始时间: 2011年3月2日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
290

研究概览

简要总结

The mean age of the 291 patients was 61.6 years (SD, 14.4); 66.2% (n = 192) were men, and 84.4% (n = 244) required mechanical ventilation during their ICU stay (median duration of ventilation, 12 days [range, 0-134]). At 6 and 12 months after ICU discharge, 75.3% (n = 219 [112 intervention, 107 control]) and 69.4% (n = 202 [107 intervention, 95 control]), respectively, completed follow-up. Overall mortality was 13.7% at 6 months (40 deaths [21 intervention, 19 control]) and 18.2% at 12 months (53 deaths [27 intervention, 26 control]). Among patients in the intervention group, 104 (70.3%) received the intervention at high levels of integrity. There was no significant difference in change of mean MCS scores (intervention group mean at baseline, 49.1; at 6 months, 52.9; change, 3.79 score points [95% CI, 1.05 to 6.54] vs control group mean at baseline, 49.3; at 6 months, 51.0; change, 1.64 score points [95% CI, -1.22 to 4.51]; mean treatment effect, 2.15 [95% CI, -1.79 to 6.09]; P = .28). Conclusions and Relevance : Among survivors of sepsis and septic shock, the use of a primary care–focused team-based intervention, compared with usual care, did not improve mental health–related quality of life 6 months after ICU discharge. Further research is needed to determine if modified approaches to primary care management may be more effective.

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • Survivors of severe sepsis or septic shock (ICD-10: A41)
  • - at least two SIRS criteria
  • - at least one organ dysfunction
  • - sufficient German language skills
  • - Patients have primary care provider

排除标准

  • - Dementia (TICSM < 27)
  • - guardianship before sepsis
  • - nursing home residents
  • - severe language/speech disorder
  • - deaf or blind patients
  • - insufficiant German language skills

研究者

发起方
Center for Sepsis Control & Care, Universitätsklinikum Jena

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