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:
Chinese PLA General Hospital
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HISTORY
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-17 | OTHER | Chinese PLA general hospital | View |