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Renal InjuryNCT00855036

Prospective Evaluation of Blunt Renal Injury in Children

An observational study of Renal Injury, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 month to 17 years
Conditions the study is for
Renal Injury
What is being tested?
Attenuated bedrest
Type of treatment
Pill or oral medicine
How many people
100 participants
Where
1 siteUnited States
Study dates
Aug 2008to 31 Aug 2025
Phase
Observational
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 1 month to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

Other trials in United States

About this study

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.

Read the detailed description

The current management for blunt renal injury in children is based on level 5 evidence, which is the lowest score. Essentially, empiric decisions about therapy without physiologic rationale have been permeated through generations of teaching. Patients are therefore managed by historical opinion, borrowing some principles from spleen and liver injuries. Over the past few decades all authors have agreed that non-operative management should be followed in all these patients as almost all injuries will heal with preservation of renal function. However, as opposed to spleen and liver injuries, there are no published guidelines for a non-operative management scheme. The kidney possesses important anatomic and physiologic differences when compared to the intraperitoneal solid organs that may allow for a distinct method of management. Therefore, we conducted a retrospective review to examine the natural history of these injuries and identify potential recommendations for management (IRB 07 12-186X). In patients with isolated renal injury (n = 65), mean length of bedrest was 3.8 +/- 1.9 days resulting in a mean length of stay of 3.8 +/- 3.1 days. There were no transfusions in these patients. There were 3 patients readmitted after discharge, 2 for pain control, and one for new hematuria after discharge. There were 15 patients discharged with persistent hematuria, none of whom suffered long term sequelae. Children were released from bedrest in attending-specific manner which was a wide array of management schemes. Our data suggests the risk of significant hemorrhage from blunt renal trauma is low. Further, clearance of hematuria may not be a good marker for therapy. Therefore, a period of bedrest with serial blood and urine monitoring may not be justified, and there is clearly a role for prospective application of a single management protocol to validate at least one protocol for other institutions to follow.

In the retrospective data, we found one patient developed intermittent hypertension. However, identifying this one patient requires that the hypertension is documented in our medical record, which means we may miss those patients managed by their pediatricians. More concerning is that we may be missing patients who have hypertension. These potential patients may get well into adulthood before the hypertension is detected which is why this study is imperative to define the natural history of renal healing, quantify the risk of hypertension, and potentially identify predictors of this complication.

The management protocol currently being followed and proposed for this study will include one night of bedrest and then the patient may be ambulatory the next day. From this point, patients will be managed in the hospital until they meet general discharge criteria. Discharge criteria are adequate pain control with oral pain medications and tolerating regular diet.

Conditions
Renal Injury
Being tested
Attenuated bedrest
Keywords
blunt renal injury, kidney laceration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attenuated bedrestOther

    Also called Renal Laceration

    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

Study groups in NCT00855036
Study groupRoleWhat they receive
Renal InjuryAll patients who have a discernable injury to the renal parenchyma on CT scan from blunt trauma
Receives: Other: Attenuated bedrest

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypertension

    Measured: 3 years

Secondary outcomes (4)
  1. Time to clear hematuria

    Measured: 2 months

  2. length of stay

    Measured: 2 weeks

  3. degree of injury

    Measured: 1 day

  4. complications

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2009 (estimated)
  2. Study startAug 2008
  3. Primary completion31 Aug 2025
  4. Study completion31 Aug 2025

Why it stopped: Will be joining a consortium study with the same protocol

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00855036
Sponsor's protocol ID
STUDY00003106
Other IDs
11120119
Status last verified
Aug 2025
First submitted
2 Mar 2009
Last updated
29 Oct 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Renal Injury, run by Children's Mercy Hospital Kansas City at 1 site in United States.

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 5 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: stopped early, as of the sponsor's last update on 29 Oct 2025. 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 United States. 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?

The study was stopped early (reason given: Will be joining a consortium study with the same protocol). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypertension (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Oct 2025.

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