Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416013
Status:
UNKNOWN
Last Update Posted:
2010-10-07
First Post:
2006-12-26
Brief Title:
Correlations Between BNP Dry Weight and Between Troponin Mortality in Hemodialysis Patients
Sponsor:
Eastern Virginia Medical School
Organization:
Eastern Virginia Medical School
Study Overview
Official Title:
Correlations Between BNP and Dry Weight and Between Troponin and Mortality in Hemodialysis Patients
Status:
UNKNOWN
Status Verified Date:
2010-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Beta Natriuretic Peptide BNP is regarded as the most sensitive test for congestive heart failure CHF BNP has also been found to be highly predictive of other conditions including pulmonary hypertension pulmonary embolism and in the general population where mild increases are associated with stroke and heart attack BNP is also weakly and variably correlated with renal function
We believe that each dialysis patient will have an ideal or dry BNP level which will accurately and reproducibly reflect their optimal fluid status Secondary hypotheses are that baseline BNP and troponin as well as changes in BNP and troponin during dialysis will be highly predictive of mortality and adequacy of dialysis
We believe that each dialysis patient will have an ideal or dry BNP level which will accurately and reproducibly reflect their optimal fluid status Secondary hypotheses are that baseline BNP and troponin as well as changes in BNP and troponin during dialysis will be highly predictive of mortality and adequacy of dialysis
Detailed Description:
Plasma BNP is regarded as the most sensitive test for congestive heart failure CHF Multiple studies have shown that BNP is a distress hormone released by the distended left ventricular myocardium which correlates significantly with left ventricular wedge pressure and all-cause mortality in those with CHF and acute coronary syndromes BNP has also been found to be highly prognostic across a wide variety of other conditions including pulmonary hypertension pulmonary embolism and in the general population where mild increases are associated with stroke and heart attack BNP is weakly and variably correlated with renal function How much of this elevation is related to renal clearance or the perturbations of the circulation that uremia hypertension and chronic fluid overload cause is speculative
There is a paucity of information about BNP levels in hemodialysis HD patients Intuitively BNP levels should be an ideal marker for left ventricular preload or dry weight in the HD population Furthermore since BNP has a short half-life of 20 minutes serial measurements during dialysis would be expected to rapidly reflect ultrafiltration and fluid status Currently the amount of fluid removed during dialysis is defined clinically by inter-dialysis weight gain hypertension edema or dyspnea Accurate assessment of ideal or dry weight is critically important in HD patients as both fluid overload and intravascular dehydration can have fatal consequences in this very frail population
The few published articles on BNP as a marker for adequacy of dialysis have given conflicting data and have been flawed by both small sample size and not doing sequential measurements on each patient
Cardiac troponins are well-established markers of myocardial injury Both troponin I and T subtypes are regulatory proteins that help coordinate the actions of actin and myosin Existing both in the cytosol and in the structure of the myocardium their release is believed to correlate with the breakdown of actin and myosin in the area of myocardial damage Elevated troponin levels have also been correlated with pulmonary embolism and other sources of right heart strain Their use in the setting of patients with ESRD has been less clear Sampling of asymptomatic ESRD patients found a significant percentage of them to have elevated troponins Proposed mechanisms for this increase include impaired renal excretion left ventricular hypertrophy endothelial dysfunction stretch mediated troponin release and leakage of cytoplasmic free troponin secondary to poor membrane integrity Regardless of the mechanism a large study of asymptomatic patients found significantly increased mortality in those with increased troponins
While the correlation between increased troponins and mortality has been shown the effects of hemodialysis on troponin levels has yet to be demonstrated in published studies
HYPOTHESIS We believe that each dialysis patient will have an ideal or dry BNP level which will accurately and reproducibly reflect their optimal fluid status Subsidiary hypotheses are that baseline BNP and troponin as well as changes in BNP and troponin during dialysis will be highly predictive of mortality and adequacy of dialysis
There is a paucity of information about BNP levels in hemodialysis HD patients Intuitively BNP levels should be an ideal marker for left ventricular preload or dry weight in the HD population Furthermore since BNP has a short half-life of 20 minutes serial measurements during dialysis would be expected to rapidly reflect ultrafiltration and fluid status Currently the amount of fluid removed during dialysis is defined clinically by inter-dialysis weight gain hypertension edema or dyspnea Accurate assessment of ideal or dry weight is critically important in HD patients as both fluid overload and intravascular dehydration can have fatal consequences in this very frail population
The few published articles on BNP as a marker for adequacy of dialysis have given conflicting data and have been flawed by both small sample size and not doing sequential measurements on each patient
Cardiac troponins are well-established markers of myocardial injury Both troponin I and T subtypes are regulatory proteins that help coordinate the actions of actin and myosin Existing both in the cytosol and in the structure of the myocardium their release is believed to correlate with the breakdown of actin and myosin in the area of myocardial damage Elevated troponin levels have also been correlated with pulmonary embolism and other sources of right heart strain Their use in the setting of patients with ESRD has been less clear Sampling of asymptomatic ESRD patients found a significant percentage of them to have elevated troponins Proposed mechanisms for this increase include impaired renal excretion left ventricular hypertrophy endothelial dysfunction stretch mediated troponin release and leakage of cytoplasmic free troponin secondary to poor membrane integrity Regardless of the mechanism a large study of asymptomatic patients found significantly increased mortality in those with increased troponins
While the correlation between increased troponins and mortality has been shown the effects of hemodialysis on troponin levels has yet to be demonstrated in published studies
HYPOTHESIS We believe that each dialysis patient will have an ideal or dry BNP level which will accurately and reproducibly reflect their optimal fluid status Subsidiary hypotheses are that baseline BNP and troponin as well as changes in BNP and troponin during dialysis will be highly predictive of mortality and adequacy of dialysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None