跳至主要内容
临床试验/NCT07837219
NCT07837219尚未招募不适用

Continuous Renal Replacement Therapy in the Aging and Frail Critically Ill Patient (CRRT-AF): A Nationwide Population-Based Cohort Study of Frailty, Age, and Clinical Outcomes

Karolinska Institutet0 个研究点目标入组 22,000 人开始时间: 2026年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
22,000
主要终点
30-day mortality

研究概览

简要总结

This nationwide observational cohort study will investigate the association between frailty, chronological age, and clinical outcomes in critically ill patients receiving continuous renal replacement therapy (CRRT) in Sweden. Using data from the Swedish Intensive Care Registry, the study will assess whether the Clinical Frailty Scale (CFS) and other measures of comorbidity and illness severity provide prognostic information beyond chronological age. Outcomes will include 30-day mortality, intensive care unit length of stay, and mortality at 60, 90, and 365 days following ICU admission. The study aims to contribute to more individualized assessment of critically ill patients who may require CRRT.

详细描述

This is a nationwide, registry-based observational cohort study of critically ill patients treated in intensive care units in Sweden. The study will use data from the Swedish Intensive Care Registry (SIR), which collects information from intensive care units across Sweden.

The primary focus is on critically ill patients receiving continuous renal replacement therapy (CRRT), with particular emphasis on older patients and the prognostic role of frailty. The study will investigate whether the Clinical Frailty Scale (CFS) and measures of comorbidity and illness severity provide prognostic information beyond chronological age.

The cohort will include eligible adult ICU patients receiving CRRT during their ICU stay. Baseline characteristics, including age and sex, will be assessed at ICU admission. Illness severity will be described using the Simplified Acute Physiology Score 3 (SAPS3), including estimated mortality risk. Additional variables will include comorbidities, ICU admission characteristics, discharge diagnosis, and CRRT-related treatment information available in the registry.

Mortality follow-up will be conducted through available registry data and linkage to the Swedish Cause of Death Register. Outcomes will be assessed at predefined time points, including 30, 60, 90, and 365 days following ICU admission.

The study is observational and registry-based. Investigators will not assign CRRT treatment or perform research procedures on patients. Statistical analyses will include descriptive methods, survival analyses, and multivariable regression to evaluate associations between frailty, age, illness severity, and clinical outcomes.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 18 years or older. Patients treated in an intensive care unit in Sweden. Patients receiving continuous renal replacement therapy (CRRT) during the ICU stay.
  • •ICU admissions occurring between January 1, 2012, and August 15, 2024, subject to confirmation of the final study period.

排除标准

  • •Age below 18 years. No treatment with CRRT during the ICU stay. Concealed or temporary personal identity number. Invalid registration date of death. Emigration within 30 days after ICU admission. Missing SAPS3 score.

研究组 & 干预措施

Critically ill patients with AKI and need for CRRT

Critically ill patients with AKI and need for (the intervention) CRRT

结局指标

主要结局

30-day mortality

时间窗: Within 30 days after ICU admission.

All-cause mortality assessed following ICU admission using mortality data available through the Swedish Intensive Care Registry and registry linkage.

次要结局

  • Intensive care unit length of stay(During the index ICU admission.)
  • 60-day mortality(Within 60 days after ICU admission.)
  • 90-day mortality(Within 90 days after ICU admission.)
  • 365-day mortality(Within 365 days after ICU admission.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Max Bell

Associate Professor, Senior Lecturer

Karolinska Institutet

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