RUBBY: Reduction of Bedrest Time of Post Percutaneous Renal Biopsy Patients

Sponsor
Hospital de Clinicas de Porto Alegre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04629235
Collaborator
(none)
140
1
2
18
7.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: wonder around
  • Behavioral: bedrest
N/A

Detailed Description

Percutaneous renal biopsy (BRP) is an important procedure for the diagnosis, prognostic evaluation and therapeutic orientation of several kidney diseases. Although it is considered a safe procedure, BRP complications can occur and, most of the time, are related to the risk of bleeding and the main consequence of BRP. Complications include macroscopic hematuria and hematoma requiring blood transfusion, surgical intervention, or invasive procedure. Since hemorrhagic complications continue to be the highest risk after BRP due to severity and potential life-threatening risk, there is an effort to minimize the risk of bleeding by checking blood clotting markers prior to the procedure, uncontrolled hypertension and the use of antiplatelet drugs and anticoagulants. The relevance of this study is to seek better evidence for clinical practice, considering the lack of Brazilian studies on the subject and the positive impact on patient comfort, besides the reduction of costs for the institution and overload in the work of the multidisciplinary team. In addition, it will contribute to the strengthening of the use of NOC in clinical practice and to the improvement of nursing knowledge.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Reduction of Bedrest Time of Post Percutaneous Renal Biopsy Patients (RBP) Evaluated by Nursing Outcomes Classification (NOC): a Randomized Clinical Trial
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 24 hours of bedrest

- 24 hours of bedrest

Behavioral: bedrest
24 hours of bedrest

Experimental: Intervention group

- Wonder around after 8 hours of bedrest

Other: wonder around
wonder around after 8 hours of bedrest

Outcome Measures

Primary Outcome Measures

  1. NOC Blood coagulation (0409) [24 hours]

    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.

Secondary Outcome Measures

  1. NOC Circulation status (0401) [24 hours]

    Measurement of Systolic blood pressure (040101) and Diastolic blood pressure (040102) with an inflatable cuff. Evaluated by Likert scale, being 1 the worst score and 5 best score.

  2. 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]

    The improvement of the indicators Reported pain (210201) and Facial expressions of pain (210206). Question the patient about their pain level using a Visual Analog Pain Scale or Numerical Verbal Pain Scale, asking how much they rate their pain from 0 to 10. Evaluated by Likert scale, being 1 the worst score and 5 best score.

  3. NOC Comfort status: physical (2010) [24 hours]

    Maintenance of Physical well-being (201002) and Comfortable position (201004). Question the patient about physical well-being and see if he has characteristics, for example: good physical mobility; feels comfortable; normal breathing; absence or control of pain. Ask the patient if he is comfortable with his body position. Check the need to use non-pharmacological (pillow, cushion, etc.) and/or pharmacological methods to be able to position yourself comfortably. Evaluated by Likert scale, being 1 the worst score and 5 best score.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All patients undergoing renal biopsy at Hospital de Clínicas de Porto Alegre (HCPA);

  • Both sexes;

  • Aged 18 years or older.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul Brazil 90035-903

Sponsors and Collaborators

  • Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Amália de Fátima Lucena, Hospital de Clínicas de Porto Alegre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT04629235
Other Study ID Numbers:
  • 170430
First Posted:
Nov 16, 2020
Last Update Posted:
Nov 17, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital de Clinicas de Porto Alegre

Study Results

No Results Posted as of Nov 17, 2020