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Terminated OBSERVATIONAL NCT00855036

Prospective Evaluation of Blunt Renal Injury in Children

Sponsor: Children's Mercy Hospital Kansas City

Conditions Renal Injury
Interventions Attenuated bedrest
Updated 18 times since 2017 Last updated: Oct 28, 2025 Started: Aug 31, 2008 Primary completion: Aug 31, 2025 Completion: Aug 31, 2025
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Will be joining a consortium study with the same protocol

This observational or N/A phase trial investigates Renal Injury and is currently terminated or withdrawn. Children's Mercy Hospital Kansas City leads this study, which shows 18 recorded versions since 2008 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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....

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.

Status Flow

~Jan 2017 – ~Apr 2018 · 15 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Feb 2019 · 8 months · monthly snapshot~Feb 2019 – ~Aug 2019 · 6 months · monthly snapshot~Aug 2019 – ~Jan 2021 · 17 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Nov 2021 · 9 months · monthly snapshot~Nov 2021 – ~Mar 2022 · 4 months · monthly snapshot~Mar 2022 – ~Feb 2023 · 11 months · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Mar 2024 · 12 months · monthly snapshot~Mar 2024 – ~Jun 2024 · 3 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshot~Feb 2025 – ~Nov 2025 · 9 months · monthly snapshot~Nov 2025 – present · 5 months · monthly snapshot~Jan 2026 – present · 3 months · monthly snapshot

Change History

18 versions recorded
  1. Jan 2026 — Present [monthly]

    Terminated

  2. Nov 2025 — Present [monthly]

    Terminated

    Status: Active Not RecruitingTerminated

  3. Feb 2025 — Nov 2025 [monthly]

    Active Not Recruiting

  4. Sep 2024 — Feb 2025 [monthly]

    Active Not Recruiting

  5. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting

Show 13 earlier versions
  1. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting

    Status: RecruitingActive Not Recruiting

  2. Mar 2024 — Jun 2024 [monthly]

    Recruiting

  3. Mar 2023 — Mar 2024 [monthly]

    Recruiting

  4. Feb 2023 — Mar 2023 [monthly]

    Recruiting

  5. Mar 2022 — Feb 2023 [monthly]

    Recruiting

  6. Nov 2021 — Mar 2022 [monthly]

    Recruiting

  7. Feb 2021 — Nov 2021 [monthly]

    Recruiting

  8. Jan 2021 — Feb 2021 [monthly]

    Recruiting

  9. Aug 2019 — Jan 2021 [monthly]

    Recruiting

  10. Feb 2019 — Aug 2019 [monthly]

    Recruiting

  11. Jun 2018 — Feb 2019 [monthly]

    Recruiting

  12. Apr 2018 — Jun 2018 [monthly]

    Recruiting

    Phase: NANone

  13. Jan 2017 — Apr 2018 [monthly]

    Recruiting NA

    First recorded

Aug 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Children's Mercy Hospital Kansas City
  • Phoenix Children's Hospital
Data source: Children's Mercy Hospital Kansas City

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations