Study of Patients With Acute Renal Failure on CVVH

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.

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Key information

Conditions

Renal Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

5 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

To determine the underlying etiology of the decrease in urine output seen with the institution of CVVH by examining patient's physiologic hormonal responses.

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Children's Healthcare of Atlanta

Other

Registry information

Official study title

The Role of Hemodynamics, Cytokine Response, and Modulators of Apoptosis on Urine Output in Patients With Acute Renal Failure on CVVH

Important dates

Study start: 2005
Primary completion: 2010
Study completion: 2010
First posted: Sep 21, 2005
Registry last updated: Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed