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Effect of low-dose of tolvaptan combined with standard hydration on the incidence of contrast-induced acute kidney injury in high risk patients

Effect of low-dose of tolvaptan combined with standard hydration on the incidence of contrast-induced acute kidney injury in high risk patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028834
Enrollment
Unknown
Registered
2020-01-05
Start date
2020-01-01
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contast-induced Acute Kidney Injury

Interventions

Experimental group 1:Low dose of tolvaptan (3.75mg) and standard intravenous hydration
Experimental group 2:High dose of tolvaptan (7.5mg) and standard intravenous hydration
Control group:Standard intravenous hydration

Sponsors

Zhongda Hospital of Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Volunteered to participate in this trial and signed informed consent; (2) Aged 18 to 85 Years; (3) Planned coronary interventional procedures; (4) AGEF scores>1.16; (5) No associated contraindications.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to iodine-containing compounds and patients who meet the contraindications in the instructions of tolvaptan: patients who are allergic to the clinical application of tolvaptan; patients in urgent need of rapidly increasing serum sodium concentration; patients with hypernatremia;patients who are insensitive to thirst or unable to respond normally to thirst; patients with hypovolemic hyponatremia; patients with anuria; Combined with potent CYP3A inhibitors; 2. Lactation, pregnancy; 3. Present or suspected acute kidney injury; 4. Use tolvaptan, contrast agent and renal toxicity drug within 1 week; 5. Severe renal insufficiency requiring hemodialysis; 6. Use IABP, acute heart failure, liver failure, connective tissue disease, tumor, severe infectious disease, cardiogenic shock in hospital, sudden cardiac death, etc.

Design outcomes

Primary

MeasureTime frame
Incidence of contrast-induced acute kidney injury;

Secondary

MeasureTime frame
(1) the actual or percent (%)change of serum creatinine, eGFR, sodium, and brain natriuretic peptide within 72 h after the administration of contrast medium,and abdominal CT was performed 24 hours after surgery to evaluate the residual contrast agent;(2) major postprocedural in-hospital adverse events, including cardiogeni;

Countries

China

Contacts

Public ContactGaoliang Yan

Zhongda Hospital of Southeast University

yanshipingguo@163.com+86 18761890380

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026