Prospective Evaluation of Blunt Renal Injury in Children

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Children's Mercy Hospital Kansas City
Sponsor:
Collaborator:
Phoenix Children's Hospital
Information provided by (Responsible Party):
Shawn St. Peter, Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00855036
First received: March 2, 2009
Last updated: February 13, 2013
Last verified: February 2013

March 2, 2009
February 13, 2013
August 2008
August 2015   (final data collection date for primary outcome measure)
Hypertension [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00855036 on ClinicalTrials.gov Archive Site
  • Time to clear hematuria [ Time Frame: 2 months ] [ Designated as safety issue: No ]
  • length of stay [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • degree of injury [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Prospective Evaluation of Blunt Renal Injury in Children
Prospective Evaluation of Blunt Renal Injury in Children

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Renal Injury
Other: Attenuated bedrest
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
Other Name: Renal Laceration
Renal Injury
All patients who have a discernable injury to the renal parenchyma on CT scan from blunt trauma
Intervention: Other: Attenuated bedrest
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
August 2015
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Under 18 years of age
  • blunt renal injury

Exclusion Criteria:

  • known bleeding disorder or genitourinary anomaly that would alter the course of recovery from a renal injury
Both
1 Month to 17 Years
No
Contact: Shawn D St. Peter, MD 816 983 6479 ext 6465 sspeter@cmh.edu
Contact: Susan W Sharp, PhD 816 983 6670 ext 6670 swsharp@cmh.edu
United States
 
NCT00855036
08 07 110
No
Shawn St. Peter, Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
Phoenix Children's Hospital
Principal Investigator: Shawn D St. Peter, MD Children's Mercy Hospital Kansas City
Children's Mercy Hospital Kansas City
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP