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

NCT07394959 | Recruiting DMC

• 2 other identifiers: ReDS guiding hydraton2024-17
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; Chronic Kidney Disease; Elderly

Keywords

contrast induced acute kidney injury; acute pulmonary edema

Outcome Measures

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

  3 days after procedure

Secondary Outcomes (5)

• Acute kidney injury

  2 days after procedure

• Acute pulmonary edema

  7 days after procedure

• Renal replacement therapy

  12 months after procedure

• Persistent renal insufficiency

  3 months after procedure

• Cardiovascular adverse events

  12 months after procedure

Study Arms (2)

Tailored hydration guided by ReDS system

EXPERIMENTAL

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

Cntrol group

NO INTERVENTION

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.

Interventions

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.

Tailored hydration guided by ReDS system

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Acute decompensated severe heart failure or cardiogenic shock;
• \. Malignant tumors, severe renal failure (estimated glomerular filtration rate \< 30 ml/min);
• \. Respiratory failure;
• \. Used contrast media within one week;
• \. Have allergic to contrast medium

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA general hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 35981838 BACKGROUND

• 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.

  PMID: 21972403 BACKGROUND

• 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.

  PMID: 24856027 BACKGROUND

• 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.

  PMID: 30571493 BACKGROUND

• 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.

  PMID: 34169747 BACKGROUND

• 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.

  PMID: 35305904 BACKGROUND

• 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.

  PMID: 38404478 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Geng Qian, MD

CONTACT

086-010-55499209; qiangeng9396@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 31, 2026
• First Posted: February 6, 2026
• Study Start: September 20, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 28, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

CN (1)