BedrestRUBBYNCT04629235
Reduction of Bedrest Time of Post Percutaneous Renal Biopsy Patients
A study testing wonder around and bedrest in people with Bedrest, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bedrest
- What is being tested?
- wonder around and bedrest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Dec 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing renal biopsy at Hospital de Clínicas de Porto Alegre (HCPA);
- Both sexes;
- Aged 18 years or older.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: 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.
Read the 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.
- Conditions
- Bedrest
- Being tested
- wonder around, bedrest
- Keywords
- Renal Biopsy, Complications, Standardized Nursing Terminology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wonder aroundOther
wonder around after 8 hours of bedrest
bedrestBehavioural
24 hours of bedrest
| Study group | Role | What they receive |
|---|---|---|
| 24 hours of bedrest | Active comparator | - 24 hours of bedrest Receives: Behavioral: bedrest |
| Intervention group | Experimental | - Wonder around after 8 hours of bedrest Receives: Other: wonder around |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BedrestStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amália de Fátima Lucena, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629235
- Sponsor's protocol ID
- 170430
- Acronym
- RUBBY
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Fatima Lucena A, Oliveira MC, Manfro RC. Reduction of patients' bed rest time after percutaneous renal biopsy evaluated by the Nursing Outcomes Classification: Randomized clinical trial. Int J Nurs Knowl. 2024 Jul;35(3):308-316. doi: 10.1111/2047-3095.12447. Epub 2023 Sep 7.
PubMed 37676727
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Bedrest Time of Post Percutaneous Renal Biopsy Patients (RBP) Evaluated by Nursing Outcomes Classification (NOC): a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04629235
- Acronym / sponsor ID
- RUBBY / 170430
- Conditions
- Bedrest
- Keywords
- Renal Biopsy, Complications, Standardized Nursing Terminology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 24 hours of bedrest | Active comparator | Behavioral: bedrest- 24 hours of bedrest |
| Intervention group | Experimental | Other: wonder around- Wonder around after 8 hours of bedrest |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients undergoing renal biopsy at Hospital de Clínicas de Porto Alegre (HCPA);
- Both sexes;
- Aged 18 years or older.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wonder aroundwonder around after 8 hours of bedrest | Other | Intervention group |
| bedrest24 hours of bedrest | Behavioural | 24 hours of bedrest |
Primary outcome
NOC Blood coagulation (0409)
Time frame: 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.
3 secondary outcomes
NOC Circulation status (0401)
Time frame: 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
Time frame: 24 hours
NOC Comfort status: physical (2010)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Derived from this study: PubMed 37676727de Fatima Lucena A, Oliveira MC, Manfro RC. Reduction of patients' bed rest time after percutaneous renal biopsy evaluated by the Nursing Outcomes Classification: Randomized clinical trial. Int J Nurs Knowl. 2024 Jul;35(3):308-316. doi: 10.1111/2047-3095.12447. Epub 2023 Sep 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amália de Fátima Lucena principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wonder around and bedrest in people with Bedrest, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magáli Costa Oliveira (+5551982378146, magali_oliveirac@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NOC Blood coagulation (0409) (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04629235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2020.