Impact on Mortality of Screening for Kidney Disease Associated With a Specialized Intervention During Hospitalization in a Territorial Hospital Trust
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,179
- 试验地点
- 6
- 主要终点
- Mortality
研究概览
简要总结
Kidney disease in its chronic or acute form shares many risk factors for initiation, progression and prognosis with an increase in morbidity and mortality, the length of hospitalization and the cost associated with stages of increasing severity. Its overall estimated prevalence in the general population is 13% and 0.5% from stage 4, for which referral to a nephrologist is recommended to reduce mortality, slow progression of renal disease and better prepare for treatment by renal replacement. Acute kidney injury (AKI) is defined as a sudden increase in serum creatinine (Scr) with a prognostic classification of increasing severity. The population with chronic kidney disease (CKD) is often hospitalized and is frequently complicated by AKI, however CKD is asymptomatic for a long time, requiring structure screening in populations at risk.
Performing Scr assays during hospitalization is an opportunity to screen patients with severe CRD or ARI requiring specialized treatment during and after hospitalization. A nephrological opinion is recommended for patients with severe CKD and AKI.
Based on preliminary studies "MRC GARD" (NCT02938611) and "ARI TARGET" (NCT03192189), the study investigators identified the frequency of patients with increased Scr corresponding to stages ≥4 of CKD and to stage1b of ARI during their hospitalization. They found that 50% of patients hospitalized with a severe AKI had a CKD prior to their hospitalization.
The use of dosages of Scr during hospitalization has been studied for AKI but without targeting high-risk subgroups and with discordant results. The study investigators plan to carry out a pragmatic study to show that an intervention combining alerts with Scr dosage to detect severe forms of CRD and AKI during hospitalization associated with the systematic intervention of a specialized dedicated team associating nephrologist and pharmacist to the scale of a GHT will improve patient and renal survival 1 year after screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
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
- •The patient or their representative must have given their free and informed consent oral consent
- •The patient must be a member or beneficiary of a health insurance plan
- •Patient living in the Gard, France
- •Patient with abnormal dose:
- •Severe grade 4 or 5 CKD suspected in front of a GFR <30 mL / min / 1.73m2 persisting during hospitalization.
- •Acute kidney injury > stage 1 defined by an increase in serum creatinine of at least 100% in less than 7 days or a threshold greater than 354 µmol / l.
排除标准
- •The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
- •It is impossible to give the subject or their representative informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient is pregnant, parturient or breastfeeding.
- •Patient unable to express consent
- •Patient with Stage 1 Acute kidney injury defined by an increase in serum creatinine of more than 26 µmol / l in less than 48 hours or a 50% increase in serum creatinine within 7 days.
- •Patient with stage 1 to 3 CKD (glomerular filtration rate (GFR)> 30 mL / min / 1.73m2)
- •Palliative/end-of-life patients
- •Patients who died within 72 hours of receiving the signal
- •Patients hospitalized in nephrology after an emergency room visit only
- •Patients under guardianship.
研究组 & 干预措施
Standard strategy
Warning KD strategy
干预措施: WARNING KD (Other)
结局指标
主要结局
Mortality
时间窗: 12 Months
Information taken from national database
次要结局
- Evaluation of the satisfaction carers of patients in the interventional group during hospitalization(end of the interventional strategy phase (minimum 3 months, maximum 12 months))
- Duration of initial hospitalization(12 Months)
- Mortality(30 days)
- Emergency start of renal support management(12 Months)
- Which autonomous support techniques used(12 Months)
- Duration of rehospitalizations(12 Months)
- Causes of rehospitalizations(12 Months)
- Prevalence of drug prescriptions slowing down the progression of the kidney disease and treating complications(12 Months)
- Evaluation of patient satisfaction of patients in the interventional group(12 months)
- Need for renal support(12 Months)
- Rate of patients with at least one inappropriate drug prescription for renal function(12 Months)
- Use of an arteriovenous fistula during the first session(12 Months)
- The rate of patients with stage ≥4 CKD followed by a nephrologist(12 Months)
- Estimation of the incremental cost-efficiency ratio(12 Months)
- Evaluate the implementation of the "WARNING KD" management model at individual facilities according to the Template for Intervention Description and Replication (TIDieR) checklist.(Over the study - maximum 2 years)
- Oriented of patient towards autonomous support techniques(12 Months)
- National scale estimation of costs avoided(12 Months)
- Evaluation of the satisfaction doctors of patients in the interventional group during hospitalization(12 Months)