Reduction of Bedrest Time of Post Percutaneous Renal Biopsy Patients
RUBBY
1 other identifier
interventional
140
1 country
1
Brief Summary
To compare the reduction of the bedrest time of the patient after percutaneous renal biopsy from 24 hours to 8 hours in relation to the occurrence of complications evaluated by the Nursing Outcome Classification (NOC) indicators.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedNovember 17, 2020
November 1, 2020
1 year
October 30, 2020
November 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NOC Blood coagulation (0409)
The primary outcome will be constituted of the absence of bleeding, measured according to the clinical indicators Bleeding (040902), Bruising (040903) and Hematuria (040918). Checked by visual inspection at the puncture location. Check hematuria by visual inspection and test with reagent strips. Evaluated by Likert scale, being 1 the worst score and 5 best score. NOC Blood loss severity (0413): Meansurement of indicators Abdominal distension (041306) and Skin and mucous membrane pallor (041313). Assess the abdominal distension of the patient in the supine position, through inspection and palpation. Assess pallor by inspecting the extremities and mucous membranes, associated with the evaluation of capillary filling with the compression/decompression of the pulp of one or more digits. Evaluated by Likert scale, being 1 the worst score and 5 best score.
24 hours
Secondary Outcomes (3)
NOC Circulation status (0401)
24 hours
NOC Pain level (2102) as assessed by Visual Analog Pain Scale or Numerical Verbal Pain Scale, asking how much they rate their pain from 0 to 10
24 hours
NOC Comfort status: physical (2010)
24 hours
Study Arms (2)
24 hours of bedrest
ACTIVE COMPARATOR\- 24 hours of bedrest
Intervention group
EXPERIMENTAL\- Wonder around after 8 hours of bedrest
Interventions
Eligibility Criteria
You may qualify if:
- All patients undergoing renal biopsy at Hospital de Clínicas de Porto Alegre (HCPA);
- Both sexes;
- Aged 18 years or older.
You may not qualify if:
- Patients with the following risk factors for complications;
- More than two punctures during the procedure;
- Larger gauge needle;
- Uncontrolled blood pressure;
- Blood clotting disorders and use of antiplatelet agents (aspirin or clopidogrel), or use of anticoagulants;
- Bedridden patients and patients unable to adequately to ambulate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amália de Fátima Lucena
Hospital de Clínicas de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2020
First Posted
November 16, 2020
Study Start
December 1, 2020
Primary Completion
December 1, 2021
Study Completion
June 1, 2022
Last Updated
November 17, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share