Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00855036 |
| Other study ID # |
11120119 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2008 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Children's Mercy Hospital Kansas City |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
