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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 af

Первичные конечные точки

• Contrast induced acute kidney injury [Срок оценки: 3 days after procedure]

Вторичные конечные точки (5)

• Acute kidney injury [Срок оценки: 2 days after procedure]
• Acute pulmonary edema [Срок оценки: 7 days after procedure]
• Renal replacement therapy [Срок оценки: 12 months after procedure]
• Persistent renal insufficiency [Срок оценки: 3 months after procedure]
• Cardiovascular adverse events [Срок оценки: 12 months after procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Chinese PLA general hospital — Пекин

Публикации

• 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
• 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
• 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
• 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
• 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
• 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 In PMID 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. PMID 38404478

Идентификаторы

NCT: NCT07394959 · ReDS guiding hydraton · 2024-17

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗