NCT04629235

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

1 year

First QC Date

October 30, 2020

Last Update Submit

November 16, 2020

Conditions

Keywords

Renal BiopsyComplicationsStandardized Nursing Terminology

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

Behavioral: bedrest

Intervention group

EXPERIMENTAL

\- Wonder around after 8 hours of bedrest

Other: wonder around

Interventions

wonder around after 8 hours of bedrest

Intervention group
bedrestBEHAVIORAL

24 hours of bedrest

24 hours of bedrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Interventions

Bed Rest

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Amália de Fátima Lucena

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Magáli Costa Oliveira

CONTACT

Amália de Fátima Lucena

CONTACT

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

Locations