Clinical Trial: The Role of CVP in Patients With Cardio-renal Syndromes

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: The Role of Central Venous Pressure in Patients With Cardio-renal Syndromes Type 1 and Type 2

Brief Summary: The aim of the study is to explore association between increased central venous pressure, Ejection Fraction and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1 and 2. The pilot study was set to provide the expected correlation coefficient for a sample size determination of the subsequent study.

Detailed Summary:

OBJECTIVES

The aim of the study is to explore association between increased central venous pressure (CVP), Ejection Fraction (EF) and renal dysfunction (eGFR) in patients with Cardio-Renal Syndromes type 1 and 2.

BACKGROUND

The pathophysiology of impaired renal function in cardiovascular disease is multifactorial. Recent investigations suggest that management of patients based on low-flow theory does not lead to improved outcomes. Relative importance of right heart dysfunction (manifested as increased CVP) has not been evaluated . Precise understanding of bidirectional pathways by which the heart and kidneys influence each other is necessary to define optimal treatment strategies specific to the subtypes, as therapies directed towards one organ system may have beneficial or unfavorable effects on the other.

METHODS

The study is of non-experimental (observational) type, based on retrospective chart review. The patients' personal identifiers are concealed and an anonymized datasets used (unique code given to each patient, which is kept secure under the control of hospital staff).


Sponsor: Tbilisi State University

Current Primary Outcome: renal impairment (defined as a Glomerular Filtration Rate less than 60 mL/min per 1.73 m2) [ Time Frame: through study completion, an average of 1 year ]

Estimated Glomerular Filtration Rate has been assessed with the Modification of Diet in Renal Disease formula


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Tbilisi State University

Dates:
Date Received: May 16, 2016
Date Started: January 2011
Date Completion: October 2016
Last Updated: June 2, 2016
Last Verified: June 2016