Study on the Safety of Easing Bed Rest Restrictions After Kidney Biopsy

JRCT ID: jRCT1040240010

Registered date:08/04/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Kidney diseases
• Date of first enrollment: 11/04/2024
• Target sample size: 179
• Study type: Interventional
• Intervention(s): Alleviation of the post-renal biopsy rest requirements compared to the methods previously practiced at our institution

Outcome(s)

• Primary Outcome: The proportion of patients who underwent transfusion or endovascular treatment due to bleeding complications after relaxation of post-renal biopsy rest within 4 hours

Secondary Outcome

1.The proportion of patients who exhibited bleeding symptoms (intractable back or abdominal pain, unstable vital signs) after relaxation of post-renal biopsy rest.
2. The proportion of patients who developed gross hematuria after relaxation of post-renal biopsy rest.
3. The proportion of patients who required extended hospitalization due to complications.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria
1. Patients who are 18 years of age or older and are independent in activities of daily living, and undergo percutaneous renal biopsy in the Department of Nephrology of our hospital.
2. Patients with preserved renal function (eGFR > 30 mL/min/1.73m2).
3. Patients whose blood pressure on the day of renal biopsy is managed to be less than 160/100 mmHg.
4. Patients for whom multiple nephrologists, including the principal investigator (Takamasa Iwakura), a specialist in nephrology, have determined a low risk of complications based on renal morphology depicted by ultrasound.
5. Patients for whom consent has been obtained by signing the informed consent form for participation in this study.

Exclude criteria

Patients who meet any of the following criteria will not be included in this study:

1. Patients who show coagulation abnormalities (prothrombin time, activated partial thromboplastin time prolongation) or thrombocytopenia (platelet count < 100,000/uL) on admission tests.
2. Patients who show anemia (hemoglobin < 10 g/dL) on admission tests.
3. Patients suspected of renal amyloidosis based on clinical course and blood/urine tests.
4. Patients with difficult blood pressure control in the post-renal biopsy course.
5. Patients who show a hematoma of 40 mL or more on ultrasound examination at the end of renal biopsy.
6. Patients who show a significant increase in hematoma size on ultrasound examination 1 hour after renal biopsy.
7. Patients who show bleeding symptoms (intractable back or abdominal pain, unstable vital signs) within 4 hours after renal biopsy.
8. Patients with gross hematuria.

Related Information

• Primary Sponsor: Iwakura Takamasa