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

January 31, 2026 updated by: Qian geng, Chinese PLA General Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
        • Contact:
          • Qing Yi Zhao
          • Phone Number: 086-010-55499209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tailored hydration guided by ReDS system
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
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.
No Intervention: Cntrol group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 days after procedure
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
7 days after procedure
Renal replacement therapy
Time Frame: 12 months after procedure
Hemodialysis or peritoneal dialysis
12 months after procedure
Persistent renal insufficiency
Time Frame: 3 months after procedure
Glomerular filtration rate decreased by ≥25% compared to baseline 3 months after percutaneous coronary intervention
3 months after procedure
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
12 months after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

November 28, 2026

Study Registration Dates

First Submitted

January 31, 2026

First Submitted That Met QC Criteria

January 31, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReDS guiding hydraton
  • 2024-17 (Other Identifier: Chinese PLA general hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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