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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-17 | Other Identifier | Chinese PLA general hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury | An absolute increase in serum creatinine > 0.3mg/dl within 48 hours after percutaneous coronary intervention | 2 days after procedure |
| Acute pulmonary edema | Dyspnea, significant increase in lung rales, accompanied by decreased oxygen saturation and significantly elevated brain natriuretic peptide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geng Qian, MD | Contact | 086-010-55499209 | qiangeng9396@263.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA general hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35981838 | Background | 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. | |
| 21972403 | Background |
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|
| 7 days after procedure |
| Renal replacement therapy | Hemodialysis or peritoneal dialysis | 12 months after procedure |
| Persistent renal insufficiency | Glomerular filtration rate decreased by ≥25% compared to baseline 3 months after percutaneous coronary intervention | 3 months after procedure |
| Cardiovascular adverse events | All-cause mortality, non-fatal acute myocardial infarction, unplaned revascularization for acute coronary syndrome ; readmission due to acute heart failure | 12 months after procedure |
| 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. |
| 24856027 | 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. |
| 30571493 | 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. |
| 34169747 | 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. |
| 35305904 | 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. |
| 38404478 | 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. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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