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NCT Number: NCT07394959

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored hydration guided by ReDS system

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.

Primary outcomes

  1. Contrast induced acute kidney injury

    Time frame: 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 outcomes

  1. Acute kidney injury

    Time frame: 2 days after procedure

    An absolute increase in serum creatinine > 0.3mg/dl within 48 hours after percutaneous coronary intervention

  2. Acute pulmonary edema

    Time frame: 7 days after procedure

    Dyspnea, significant increase in lung rales, accompanied by decreased oxygen saturation and significantly elevated brain natriuretic peptide

  3. Renal replacement therapy

    Time frame: 12 months after procedure

    Hemodialysis or peritoneal dialysis

  4. Persistent renal insufficiency

    Time frame: 3 months after procedure

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

  5. Cardiovascular adverse events

    Time frame: 12 months after procedure

    All-cause mortality, non-fatal acute myocardial infarction, unplaned revascularization for acute coronary syndrome ; readmission due to acute heart failure

Study contacts

Contact information is provided by the study sponsor or research team.

Geng Qian, MD

CONTACT

[email protected]

086-010-55499209

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Clinical Study on Tailored Hydration by Remote Dielectric Sensing System to Prevent Acute Renal Injury in Elderly Patients With Renal Insufficiency After Coronary Angiography

Acronym: HISTORY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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