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Coronary Artery DiseaseHISTORYNCT07394959

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

A study testing Tailored hydration guided by ReDS system in people with Coronary Artery Disease and Chronic Kidney Disease, run by Chinese PLA General Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Tailored hydration guided by ReDS system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteChina
Study dates
20 Sep 2024to 28 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Geng Qian, MD contact

086-010-55499209

qiangeng9396@263.net

China1 site, 1 recruiting

  • Chinese PLA general hospital

    Beijing, Beijing Municipality, 100853

    Cao Jiang, MD, 086-010-66937166, 301irb@sina.com

    Qing Yi Zhao, 086-010-55499209

    Recruiting

Other trials in China

About this study

Official 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

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.

Read the 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.

Being tested
Tailored hydration guided by ReDS system
Keywords
contrast induced acute kidney injury, acute pulmonary edema
Medical subject headings
Coronary Artery Disease, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tailored hydration guided by ReDS systemProcedure or 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.

Study groups in NCT07394959
Study groupRoleWhat they receive
Tailored hydration guided by ReDS systemExperimentalThe group guided by lung water monitor adjust hydration infusion rate dynamically adjusts based on the lung water parameters from the ReDS system.
Receives: Procedure: Tailored hydration guided by ReDS system
Cntrol groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 days after procedure

Secondary outcomes (5)

  1. Acute kidney injury

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

    Measured: 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

    Measured: 7 days after procedure

  3. Renal replacement therapy

    Hemodialysis or peritoneal dialysis

    Measured: 12 months after procedure

  4. Persistent renal insufficiency

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

    Measured: 3 months after procedure

  5. Cardiovascular adverse events

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

    Measured: 12 months after procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start20 Sep 2024
  3. Primary completion31 May 2026 (estimated)
  4. Study completion28 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07394959
Sponsor's protocol ID
ReDS guiding hydraton
Other IDs
2024-17
Acronym
HISTORY
Status last verified
Jan 2026
First submitted
31 Jan 2026
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mauler-Wittwer S, Sievert H, Ioppolo AM, Mahfoud F, Carrie D, Lipiecki J, Nickenig G, Fajadet J, Eckert S, Morice MC, Garot P. Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI. JACC Cardiovasc Interv. 2022 Aug 22;15(16):1639-1648. doi: 10.1016/j.jcin.2022.05.036. Epub 2022 Jul 27.

    PubMed 35981838

  • Maioli M, Toso A, Leoncini M, Micheletti C, Bellandi F. Effects of hydration in contrast-induced acute kidney injury after primary angioplasty: a randomized, controlled trial. Circ Cardiovasc Interv. 2011 Oct 1;4(5):456-62. doi: 10.1161/CIRCINTERVENTIONS.111.961391. Epub 2011 Oct 4.

    PubMed 21972403

  • Brar SS, Aharonian V, Mansukhani P, Moore N, Shen AY, Jorgensen M, Dua A, Short L, Kane K. Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial. Lancet. 2014 May 24;383(9931):1814-23. doi: 10.1016/S0140-6736(14)60689-9.

    PubMed 24856027

  • Uriel N, Sayer G, Imamura T, Rodgers D, Kim G, Raikhelkar J, Sarswat N, Kalantari S, Chung B, Nguyen A, Burkhoff D, Abbo A. Relationship Between Noninvasive Assessment of Lung Fluid Volume and Invasively Measured Cardiac Hemodynamics. J Am Heart Assoc. 2018 Nov 20;7(22):e009175. doi: 10.1161/JAHA.118.009175.

    PubMed 30571493

  • Moroni F, Baldetti L, Kabali C, Briguori C, Maioli M, Toso A, Brilakis ES, Gurm HS, Bagur R, Azzalini L. Tailored Versus Standard Hydration to Prevent Acute Kidney Injury After Percutaneous Coronary Intervention: Network Meta-Analysis. J Am Heart Assoc. 2021 Jul 6;10(13):e021342. doi: 10.1161/JAHA.121.021342. Epub 2021 Jun 25.

    PubMed 34169747

  • Mohebi R, Karimi Galougahi K, Garcia JJ, Horst J, Ben-Yehuda O, Radhakrishnan J, Chertow GM, Jeremias A, Cohen DJ, Cohen DJ, Maehara A, Mintz GS, Chen S, Redfors B, Leon MB, Stuckey TD, Rinaldi MJ, Weisz G, Witzenbichler B, Kirtane AJ, Mehran R, Dangas GD, Stone GW, Ali ZA. Long-Term Clinical Impact of Contrast-Associated Acute Kidney Injury Following PCI: An ADAPT-DES Substudy. JACC Cardiovasc Interv. 2022 Apr 11;15(7):753-766. doi: 10.1016/j.jcin.2021.11.026. Epub 2022 Mar 16.

    PubMed 35305904

  • Feng W, Zhou J, Lun Z, Zhou D, Li P, Ye J. A Comparison Between Two Different Definitions of Contrast-Associated Acute Kidney Injury for Long-Term Mortality in Patients with Chronic Kidney Disease Undergoing Coronary Angiography. Clin Interv Aging. 2024 Feb 19;19:303-311. doi: 10.2147/CIA.S452882. eCollection 2024.

    PubMed 38404478

Questions about this trial

What is this clinical trial studying?

A study testing Tailored hydration guided by ReDS system in people with Coronary Artery Disease and Chronic Kidney Disease, run by Chinese PLA General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Geng Qian, MD (086-010-55499209, qiangeng9396@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contrast induced acute kidney injury (time frame: 3 days after procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07394959, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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