Reduction of Bedrest Time of Post Percutaneous Renal Biopsy Patients (RUBBY)

Reduction of Bedrest Time of Post Percutaneous Renal Biopsy Patients (RBP) Evaluated by Nursing Outcomes Classification (NOC): a Randomized Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Bedrest
• Intervention / Treatment: Behavioral: bedrest; Other: wonder around

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Magáli Costa Oliveira; Phone Number: +5551982378146; Email: magali_oliveirac@hotmail.com
• Study Contact Backup: Name: Amália de Fátima Lucena; Phone Number: +5551981794710; Email: afatimalucena@gmail.com

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
      • Hospital de Clinicas de Porto Alegre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NOC Circulation status (0401)	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.	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	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.	24 hours
NOC Comfort status: physical (2010)	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.	24 hours

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Amália de Fátima Lucena, Hospital de Clinicas de Porto Alegre

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: October 30, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Complications; Renal Biopsy; Standardized Nursing Terminology
• Other Study ID Numbers: 170430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No