An interventional study of Tailored hydration guided by ReDS system in Coronary Artery Disease, Chronic Kidney Disease and Elderly, sponsored by Chinese PLA General Hospital. Recruiting at 1 site in China. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Prevention
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 320 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
The group guided by lung water monitor adjust hydration infusion rate dynamically adjusts based on the lung water parameters from the ReDS system.
Procedure: Tailored hydration guided by ReDS system
The control group performs the conventional hydration recommended by guidelines: administering normal saline at a rate of 1 ml/kg/h from 6 hours before procedure to 12 hours after procedure.
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.
Contrast induced acute kidney injury
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
Time frame: 3 days after procedure
Acute kidney injury
An absolute increase in serum creatinine \> 0.3mg/dl within 48 hours after percutaneous coronary intervention
Time frame: 2 days after procedure
Acute pulmonary edema
Dyspnea, significant increase in lung rales, accompanied by decreased oxygen saturation and significantly elevated brain natriuretic peptide
Time frame: 7 days after procedure
Renal replacement therapy
Hemodialysis or peritoneal dialysis
Time frame: 12 months after procedure
Persistent renal insufficiency
Glomerular filtration rate decreased by ≥25% compared to baseline 3 months after percutaneous coronary intervention
Time frame: 3 months after procedure
Cardiovascular adverse events
All-cause mortality, non-fatal acute myocardial infarction, unplaned revascularization for acute coronary syndrome ; readmission due to acute heart failure
Time frame: 12 months after procedure
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Chinese PLA General Hospital