Chronic Kidney Disease, Coronary Artery Disease, Elderly
Conditions
Keywords
contrast induced acute kidney injury, acute pulmonary edema
Brief summary
Explore the effectiveness and safety of tailored hydration guided by lung water index monitor system for prevention of acute kidney injury after percutaneous coronary intervention for elderly patients with renal insufficiency.
Detailed description
The elderly patients with coronary heart disease is often complicated with chronic kidney disease, and these high risk patients has a risk of developing contrast induced acute kidney injury after undergoing percutaneous coronary intervention. Hydration is an important prevention to reduce the risk of contrast induced acute kidney injury , but hydration may cause acute left heart failure in elderly patients with renal insufficiency. We designed to give the elderly patients necessary hydration volume to reduce the risk of contrast induced acute kidney injury, and meanwhile avoid acute pulmonary edema caused by excessive preload. This study aimed to explore tailored hydration guided by lung water monitoring to prevent contrast induced acute kidney in elderly patients with renal insufficiency undergoing percutaneous coronary intervention. This study randomly divided elderly patients who are planning to undergo coronary intervention into two groups: tailored hydration group guided by remote dielectric sensing (ReDS system) and control group. The intervention group uses ReDS system to dynamically monitor the lung water index of enrolled patient, and fluid infusion rate is dynamically adjusted by lung water index to prevent the occurrence of acute pulmonary edema. We plan to evaluate the occurrence of postoperative acute kidney injury and acute pulmonary edema in two groups during the perioperative period. We follow up both major cardiovascular events and hemodialysis events in two groups.
Interventions
PROCEDURETailored hydration guided by ReDS system
If initial lung water index is ≥35%, the hydration rate is 1ml/kg/h; If the initial lung water index is \<35% but ≥20%, the hydration rate is 2ml/kg/h; If the initial lung water index is \<20%, the hydration rate is designed to 5ml/kg/h. We re-check the lung water index after the contrast procedure. If the lung water index is \>35% or if there is a more than 2-fold increase in the lung water index compared to pre-procedure, adjust the fluid infusion rate to 0.5ml/kg/h. If the lung water index after the contrast procedure is ≥20% but \<35%, adjust the fluid infusion rate to 1ml/kg/h. If the lung water index after the contrast procedure is still \<20%, adjust the fluid infusion rate to 5ml/kg/h.
Sponsors
Chinese PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 60 years; * Patients with unstable angina pectoris are scheduled for percutaneous coronary intervention； * Patients with chronic renal disease (estimated glomerular filtration rate \< 90 ml/min); * Sign the informed consent form.
Exclusion criteria
* 1\. Acute decompensated severe heart failure or cardiogenic shock; * 2\. Malignant tumors, severe renal failure (estimated glomerular filtration rate \< 30 ml/min); * 3\. Respiratory failure; * 4\. Used contrast media within one week; * 5\. Have allergic to contrast medium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contrast induced acute kidney injury | 3 days after procedure | Increase in the creatinine level of at least 0.5 mg/dl (44 μmo/L) or at least a 25% increase from the baseline level within 2 to 3 days after PCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury | 2 days after procedure | An absolute increase in serum creatinine \> 0.3mg/dl within 48 hours after percutaneous coronary intervention |
| Acute pulmonary edema | 7 days after procedure | Dyspnea, significant increase in lung rales, accompanied by decreased oxygen saturation and significantly elevated brain natriuretic peptide |
| Renal replacement therapy | 12 months after procedure | Hemodialysis or peritoneal dialysis |
| Persistent renal insufficiency | 3 months after procedure | Glomerular filtration rate decreased by ≥25% compared to baseline 3 months after percutaneous coronary intervention |
| Cardiovascular adverse events | 12 months after procedure | All-cause mortality, non-fatal acute myocardial infarction, unplaned revascularization for acute coronary syndrome ; readmission due to acute heart failure |
Countries
China
Contacts
CONTACTGeng Qian, MD
Outcome results
None listed