Improving Patient Assessment After Acute Kidney Injury (AKI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Standard deviation of the difference between measured GFR and eGFR-creatinine and eGFR-cystatin
研究概览
简要总结
The goal of this clinical trial is to improve patient care after acute kidney injury (AKI). It has three related parts. The main questions it aims to answer are:
- Is creatinine or cystatin a more reliable assessment of kidney function after AKI?
- What are the experiences of patients after AKI?
- What interventions should be recommended to improve assessment and support of patients after AKI?
Participants will be asked to do one or more of:
- blood tests to measure kidney function in different ways
- have measurement of their body composition
- complete questionnaires about their symptoms
- have an interview with a researcher about their experiences
- discussion to develop an action plan based on findings
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Observational study workstream
- •Age 18-85 years
- •AKI stage 2 or 3 during hospital admission OR AKI stage 1 of at least 7 days duration during hospital admission
- •60-90 days after peak creatinine Qualitative interview workstream
- •Age 18-85 years
- •AKI during hospital admission
- •60-90 days after peak creatinine Participatory workshop workstream
- •Age 18-85 years
- •Relevant experience (as assessed by the investigator) which could include personal experience of an episode of hospitalised AKI as a patient of carer, experience of managing AKI or related problems in a professional capacity or knowledge of a particular community.
排除标准
- •Observational study workstream
- •Inability to give informed consent
- •No baseline creatinine available in previous 12 months
- •Pregnancy or breastfeeding
- •Current treatment with dialysis
- •Renal transplant
- •Pacemaker in situ
- •Previous amputation
- •Allergy to Omnipaque contrast agent (WP1 only)
- •Manifest thyrotoxicosis (WP1 only)
- •Ascites or significant (grade 3 to 4) peripheral oedema, defined as ≥6 mm pit, lasting for >1 minute after 5-second compression over tibia or medial malleolus (WP1 only) Qualitative interview workstream
- •Inability to give informed consent
- •No baseline creatinine available in previous 12 months
- •Current treatment with dialysis
- •Renal transplant
- •Receiving palliative care Participatory workshop workstream
- •Inability to give informed consent
- •Inability to communicate in English (the qualitative workshops will be held in English)
研究组 & 干预措施
Observational study
Patients 3 months after hospitalised acute kidney injury
干预措施: Iohexol renal clearance measurement (Diagnostic Test)
Observational study
Patients 3 months after hospitalised acute kidney injury
干预措施: Cystatin C (Diagnostic Test)
Observational study
Patients 3 months after hospitalised acute kidney injury
干预措施: Creatinine (Diagnostic Test)
Observational study
Patients 3 months after hospitalised acute kidney injury
干预措施: Metagenome analysis (Diagnostic Test)
Observational study
Patients 3 months after hospitalised acute kidney injury
干预措施: Bioimpedance analysis (Diagnostic Test)
Observational study
Patients 3 months after hospitalised acute kidney injury
干预措施: Patient reported outcome measures (Other)
Observational study
Patients 3 months after hospitalised acute kidney injury
干预措施: Measurement of physical performance (Other)
Qualitative study
Patients 3 months after hospitalised acute kidney injury
干预措施: Semi structured interview (Other)
Participatory workshops
Individuals with personal or professional experience of acute kidney injury
干预措施: Participatory workshop (Other)
结局指标
主要结局
Standard deviation of the difference between measured GFR and eGFR-creatinine and eGFR-cystatin
时间窗: 3 months
The proportion of patients with eGFR <60ml/min/1.73m2 from eGFR-cystatin compared with eGFR creatinine
时间窗: 3 months
The proportion of eligible patients who agree to participate
时间窗: 3 months
The proportion of participants who have all three measurements (eGFR-cystatin, eGFR-creatinine and measured GFR)
时间窗: 3 months
Gut microbiome composition
时间窗: 3 months
Assessed through metagenomics
Codes and themes related to patient experience after AKI, identified from systematic qualitative analysis of interview transcripts
时间窗: 3 - 12 months
Production of a document of recommended next steps through MDT development during participatory workshops
时间窗: At completion of third workshop 3 years after enrolment
次要结局
- Bias between iohexol measured GFR and each estimated GFR method (creatinine and cystatin)(3 months)
- The mean difference between eGFR-cystatin and eGFR-creatinine(3 months)
- The mean difference between iohexol measured GFR and each estimated GFR method (creatinine and cystatin)(3 months)
- Correlation between eGFR creatinine and eGFR cystatin(3 months)
- Correlation between iohexol measured GFR and each estimated GFR method (creatinine and cystatin)(3 months)
- Accuracy of eGFR creatinine and eGFR cystatin compared with iohexol measured GFR as assessed by the percentage of estimated values within 30% of measured GFR (P30)(3 months)
- Correlation of muscle mass with the percentage difference between eGFR-cystatin and eGFR-creatinine(3 months)
- Correlation of physical function with the percentage difference between eGFR-cystatin and eGFR-creatinine(3 months)
- Correlation of patient reported outcomes with the percentage difference between eGFR-cystatin and eGFR-creatinine(3 months)
- Barriers to implementation of recommendations as identified through MDT discussion at participatory workshops(At completion of third workshop 3 years after enrolment)