Study of Patients With Acute Renal Failure on CVVH

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Children's Healthcare of Atlanta.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00207909
First received: September 13, 2005
Last updated: March 14, 2012
Last verified: June 2009
  Purpose

Acute kidney failure is common in children in the Pediatric Intensive Care Unit (PICU). You are being asked to participate in this study because your child is being treated for kidney failure with continuous veno-venous hemofiltration (CVVH). CVVH is a continuous, gentle form of removing excess fluids and small wastes from the blood, similar to kidney dialysis (artificial kidney). It is an accepted therapy for temporary support of kidney failure. In some patients with acute kidney failure, beginning CVVH is followed by a temporary decrease of urine output. The reason why this happens is currently unknown. The purpose of this study is to determine why this happens.


Condition
Renal Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Hemodynamics, Cytokine Response, and Modulators of Apoptosis on Urine Output in Patients With Acute Renal Failure on CVVH

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Enrollment: 39
Study Start Date: February 2005
Detailed Description:

Acute renal failure is common in children in the pediatric intensive care unit. Renal replacement therapies such as peritoneal dialysis (PD), intermittent hemodialysis (IHD), and continuous venovenous hemofiltration (CVVH) have been used in the management of acute renal failure. CVVH is becoming increasingly utilized in pediatric acute renal failure. However, in patients who have acute renal failure, the institution of CVVH is often followed by a progression to oliguria or anuria. The underlying pathophysiology of this change is unknown. We believe that this progression is influenced by changes in the renin-angiotensin axis, cytokine response, and other modifiers of renal hemodynamics. By serially measuring components of those systems, this study will attempt to elucidate the pathophysiology of the decreased urine output seen with institution of CVVH. Once this process is understood, future studies should focus on prevention and treatment of this complication.

General Hypothesis

The decrease in urine output seen after the initiation of CVVH is associated with increased angiotensin converting enzyme (ACE) levels, increased renin activity, increased angiotensin II levels, increased atrial naturetic peptide (ANP) levels, increased endothelin-1 levels, increased arginine vasopressin (AVP) levels, and alterations of cytokine levels and modulators of apoptosis.

  Eligibility

Ages Eligible for Study:   5 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients Pediatric Intensive Care Unit @ Egleston meeting inclusion criteria / avoiding exclusion criteria.

Criteria

Inclusion Criteria:

The general goal of patient selection is to enroll all children for whom CVVH is instituted.

Inclusion criteria:

Age

  • 6 months -18 years old
  • Patients less than 6 months of age on ECMO (addendum #1)

Indication for CVVH: including, but not limited to :

  • Acute Renal Failure
  • Oliguria
  • Anuria
  • Hyperkalemia
  • Severe acidemia
  • Azotemia
  • Pulmonary Edema
  • Uremic complications
  • Severe electrolyte abnormalities
  • Drug overdose with a filterable toxin
  • Anasarca
  • Rhabdomyolysis

Exclusion Criteria:

  • Age

    • Less than 6 months old (unless on ECMO)
    • Greater than 18 years old Weight
    • Less than 5 kilograms (unless ON ECMO) Location
    • Cardiac Intensive Care Unit
    • Neonatal Intensive Care Unit

Non-adherence:

Inability or unwillingness of the legal guardian to provide consent or inability or unwillingness of the child to provide assent

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207909

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: James D Fortenberry, MD Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00207909     History of Changes
Other Study ID Numbers: 04-114, 06585
Study First Received: September 13, 2005
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:
Acute Renal Failure
Contiuous Veno Venous Hemofiltration

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014