Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury

Acute Kidney Injury Clinical Trial

Official title:

Evaluation of Catheter Placement for Renal Replacement Therapy in Patients With Acute Kidney Injury- Assessment of Dialysis Adequacy and Infection Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200120
• Other study ID #: 99904021982
• Status: Completed
• Phase: N/A
• First received: July 21, 2014
• Last updated: July 20, 2015
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury.

Description:

The purpose of this study is to examine the placement, timing, associated complications, efficacy of temporary and tunneled catheters for renal replacement therapy in patient with acute kidney injury. In particular, we will be assessing renal replacement adequacy for patients on dialysis and continuous veno-venous hemofiltration by monitoring urea reduction ratios, venous and arterial pressures. We will also be monitoring infection rates. We will compare these outcomes in patients receiving tunneled catheters and patients receiving temporary catheters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients admitted to the hospital with acute kidney injury requiring renal replacement therapy

Exclusion Criteria:

• End stage renal disease

• Chronic kidney disease 5 progression to end stage renal disease

• Outside hospital catheter placement

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Kidney Injury

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dialysis adequacy	Adequacy will be measured using urea reduction ratio for patients on intermittent hemodialysis. For continuous renal replacement therapy, we will record the maximum blood flow rate achievable. These measurements/recordings will be made on average within 1-3 days of starting therapy.	up to 7d after starting renal replacement therapy	No
Secondary	blood stream infection rates	Patients will be followed throughout their hospitalization, which can range from a few days to several weeks. Bloodstream infections within 30d of catheter placement will be recorded.	within 30d of catheter placement	Yes