About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Tailored hydration guided by ReDS system
Procedure/SurgeryIf 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Acute kidney injury
An absolute increase in serum creatinine \> 0.3mg/dl within 48 hours after percutaneous coronary intervention
Acute pulmonary edema
Dyspnea, significant increase in lung rales, accompanied by decreased oxygen saturation and significantly elevated brain natriuretic peptide
Renal replacement therapy
Hemodialysis or peritoneal dialysis
Persistent renal insufficiency
Glomerular filtration rate decreased by ≥25% compared to baseline 3 months after percutaneous coronary intervention
Sponsors and contacts
Click on the lead sponsor to view all of their trials.