Hydration Guided by Remote Dielectric Sensing (ReDS) System for Preventing Acute Kidney Injury in Elderly Patients With Renal Insufficiency for Coronary Angiography and Intervention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorChinese PLA General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Tailored hydration guided by ReDS system

    Procedure/Surgery

    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.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Tailored hydration guided by ReDS systemExperimental treatment 1 intervention
Group B: Cntrol groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Renal replacement therapy

Hemodialysis or peritoneal dialysis

Time frame
12 months after procedure
4

Persistent renal insufficiency

Glomerular filtration rate decreased by ≥25% compared to baseline 3 months after percutaneous coronary intervention

Time frame
3 months after procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.