NCT00855036

Brief Summary

The objective of this study is to evaluate the outcomes of children who have sustained blunt renal injury and to evaluate our current bed rest protocol. The variables of concern are readmission, operation, subsequent hypertension and clearance of hematuria. The specific aim of the study is to prospectively collect the clinical data of these children to validate our hospital management and to define the natural history of these lesions.

Trial Health

57
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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

August 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

October 29, 2025

Status Verified

August 1, 2025

Enrollment Period

17.1 years

First QC Date

March 2, 2009

Last Update Submit

October 28, 2025

Conditions

Renal Injury

Keywords

blunt renal injurykidney laceration

Outcome Measures

Primary Outcomes (1)

  • Hypertension

    3 years

Secondary Outcomes (4)

  • Time to clear hematuria

    2 months

  • length of stay

    2 weeks

  • degree of injury

    1 day

  • complications

    3 years

Study Arms (1)

Renal Injury

All patients who have a discernable injury to the renal parenchyma on CT scan from blunt trauma

Other: Attenuated bedrest

Interventions

Attenuated bedrestOTHER

Patients are allowed to ambulate the morning after admission and then can be discharged when eating well and pain is controlled on oral pain medication regardless of hematuria

Also known as: Renal Laceration
Renal Injury

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients under 18 who have an identifiable renal parenchymal injury on CT after blunt trauma

You may qualify if:

  • Patients with blunt renal injury
  • Less than 18 years of age at time of injury
  • Patients without known bleeding abnormalities

You may not qualify if:

  • Children without blunt renal injury
  • Children with known bleeding abnormalities
  • Patients 18 years of age and older at the time of injury
  • Inability to comply with the intended follow up
  • Patients with open/penetrating renal trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Study Officials

  • Shawn D St. Peter, MD

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 3, 2009

Study Start

August 1, 2008

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

October 29, 2025

Record last verified: 2025-08

Locations

US(1)