Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 7:45 PM
Study NCT ID:
NCT07394959
Status:
RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydration Guided by Remote Dielectric Sensing (ReDS) System for Preventing Acute Kidney Injury in Elderly Patients With Renal Insufficiency for Coronary Angiography and Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-11-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-31', 'studyFirstSubmitDate': '2026-01-31', 'studyFirstSubmitQcDate': '2026-01-31', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast induced acute kidney injury', 'timeFrame': '3 days after procedure', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Acute kidney injury', 'timeFrame': '2 days after procedure', 'description': 'An absolute increase in serum creatinine \\> 0.3mg/dl within 48 hours after percutaneous coronary intervention'}, {'measure': 'Acute pulmonary edema', 'timeFrame': '7 days after procedure', 'description': 'Dyspnea, significant increase in lung rales, accompanied by decreased oxygen saturation and significantly elevated brain natriuretic peptide'}, {'measure': 'Renal replacement therapy', 'timeFrame': '12 months after procedure', 'description': 'Hemodialysis or peritoneal dialysis'}, {'measure': 'Persistent renal insufficiency', 'timeFrame': '3 months after procedure', 'description': 'Glomerular filtration rate decreased by ≥25% compared to baseline 3 months after percutaneous coronary intervention'}, {'measure': 'Cardiovascular adverse events', 'timeFrame': '12 months after procedure', 'description': 'All-cause mortality, non-fatal acute myocardial infarction, unplaned revascularization for acute coronary syndrome ; readmission due to acute heart failure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['contrast induced acute kidney injury', 'acute pulmonary edema'], 'conditions': ['Coronary Artery Disease', 'Chronic Kidney Disease', 'Elderly']}, 'referencesModule': {'references': [{'pmid': '35981838', 'type': 'BACKGROUND', 'citation': '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': '21972403', 'type': 'BACKGROUND', 'citation': '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': '24856027', 'type': 'BACKGROUND', 'citation': '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': '30571493', 'type': 'BACKGROUND', 'citation': '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': '34169747', 'type': 'BACKGROUND', 'citation': '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': '35305904', 'type': 'BACKGROUND', 'citation': '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': '38404478', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 years;\n* Patients with unstable angina pectoris are scheduled for percutaneous coronary intervention；\n* Patients with chronic renal disease (estimated glomerular filtration rate \\< 90 ml/min);\n* Sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Acute decompensated severe heart failure or cardiogenic shock;\n* 2\\. Malignant tumors, severe renal failure (estimated glomerular filtration rate \\< 30 ml/min);\n* 3\\. Respiratory failure;\n* 4\\. Used contrast media within one week;\n* 5\\. Have allergic to contrast medium'}, 'identificationModule': {'nctId': 'NCT07394959', 'acronym': 'HISTORY', 'briefTitle': 'Hydration Guided by Remote Dielectric Sensing (ReDS) System for Preventing Acute Kidney Injury in Elderly Patients With Renal Insufficiency for Coronary Angiography and Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Clinical Study on Tailored Hydration by Remote Dielectric Sensing System to Prevent Acute Renal Injury in Elderly Patients With Renal Insufficiency After Coronary Angiography', 'orgStudyIdInfo': {'id': 'ReDS guiding hydraton'}, 'secondaryIdInfos': [{'id': '2024-17', 'type': 'OTHER', 'domain': 'Chinese PLA general hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tailored hydration guided by ReDS system', 'description': 'The group guided by lung water monitor adjust hydration infusion rate dynamically adjusts based on the lung water parameters from the ReDS system.', 'interventionNames': ['Procedure: Tailored hydration guided by ReDS system']}, {'type': 'NO_INTERVENTION', 'label': 'Cntrol group', 'description': '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': [{'name': 'Tailored hydration guided by ReDS system', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Tailored hydration guided by ReDS system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cao Jiang, MD', 'role': 'CONTACT', 'email': '301irb@sina.com', 'phone': '086-010-66937166'}, {'name': 'Qing Yi Zhao', 'role': 'CONTACT', 'phone': '086-010-55499209'}], 'facility': 'Chinese PLA general hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Geng Qian, MD', 'role': 'CONTACT', 'email': 'qiangeng9396@263.net', 'phone': '086-010-55499209'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Qian geng', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}