Ignite Creation Date:
2024-05-05 @ 11:46 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01419132
Status:
COMPLETED
Last Update Posted:
2011-11-01
First Post:
2011-08-15
Brief Title:
Troponin I Release After High Diuretic Doses
Sponsor:
University of Palermo
Organization:
University of Palermo
Study Overview
Official Title:
Effects of High Furosemide Doses Alone or With Hypertonic Saline on Troponin I Myocardial Release in Acute Decompensated Heart Failure a Double Blind Study
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
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:
Tra-HSS-Fur
Brief Summary:
High values of cardiac troponin Ct in acute heart failure ADHF identify patients pts at higher risk and worsened prognosis A Ct increase during therapy indicates the need for more appropriate intervention aimed at compensating cardiac disease and effectively minimizing myocardial wall stress and subsequent cytolysis This study evaluated the effects of an intravenous high-dose of furosemide with or without small-volume hypertonic saline solution HSSon myocardial cytolysis in ADHF pts
Detailed Description:
After randomization all patients included in the study underwent a complete physical examination including a careful check of HF signs and symptoms including BW measurement in the morning before breakfast supine and standing blood pressure BP the mean of 3 measurements and heart rate HR Fasting blood samples were drawn to determine the serum levels of Na K Cl bicarbonate albumin uric acid creatinine urea and glycemia on a daily basis during hospitalization and this was continued until a clinically compensated state was obtained The total daily output of urine was collected for measuring levels of creatinine clearance urinary Na and K A chest radiograph electrocardiogram and echocardiogram prior to commencing therapy and again when discharged In addition BNP and TNI plasma levels will be evaluated for all patients on entry and at discharge Each patient provided written informed consent prior to participating in the study
In order to determine GFR the MDRD formula Modification of Diet in Renal Disease involving 4 parameters was deployed It provides an estimate of GFR comparable or superior to other formulae with the advantage of not requiring any anthropometric measurements According to the MDRD GFR can be estimated using the following formula GFR mlmin173m2 175 x serum creatinine mg dL or μmolL884 -1154 x age years -0203 x 0742 if female and 121 if Afro-American The estimating of GFR by means of the MDRD formula is a useful and valid tool with which to obtain an index of kidney function
The echocardiography M B mode color Doppler will be performed with a Vivid 7 echocardiograph with patients in a supine position and slightly left lateral decubitus The mitral flow and the time taken for the wave to return to baseline DTE were evaluated from the apical 4 room positions placing the sample volume of pulsed Doppler at the peak of the valve leaflets during the opening Subsequently the speed of early diastolic movement Ea of mitral annulus obtained from the 4 room projection placing the sample volume of pulsed tissue Doppler onto lateral corner of the annulus was assessed as an index of left ventricular relaxation By measuring the Ea wave and the E Ea ratio the PCWP was evaluated in a quantitative way according to the following formulae
PCWP 124 E Ea 191 for those in sinus rhythm PCWP 0821 E Ea 6489 for those in atrial fibrillation Calculating dpdt The calculating of dpdt was performed by a spectral analysis of mitral regurgitation at CW Doppler Two points were chosen on the mitral regurgitation curve for the correct calculation of echocardiographic dp dt A speed 1 m sec 4 mm Hg and B speed 3 m sec 36 mm Hg The pressure gradient between these two point was reported to be 32 mmHg A - B 36 - 4 32 dPdT was calculated by dividing the pressure gradient between the two points for the temporal distance between them dP dT 32mmHg T msec
Bioelectrical impedance variables will be detected with an impedance plethysmograph using a previously-described methodology 18 This emitted an alternating sinusoidal electric current of 800 mA and an operating single frequency of 50 kHz it which was calibrated each morning using a standard resistor supplied by the manufacturer BIA is a method for detecting whole-body fluid overload and pulmonary congestion based on the theory that the accumulation of whole-body or intrathoracic fluid will conduct an electrical current passing across the body or trunk more easily leading to a decrease in whole-body or pulmonary bioimpedance Bioimpedance is a combination of resistance Rz ie the opposition of an alternating current flowing through intra- and extra-cellular ionic solutions and reactance Xc ie the capacitative component of tissue interfaces cell membranes and organelles As previous described in standard whole-body tetrapolar BIA sensing electrodes were placed on the dorsum of the wrist a line between the radial and ulnar styloid processes the dorsum of the ipsilateral foot and on a line between the medial and lateral malleoli Source electrodes were placed to overlie the head of the third metacarpal on the dorsum of the hand and the third metatarsal on the dorsum of the foot on the same side as the sensing electrodes The measurements will be performed on the right side of the body with the patients in a semi-orthopneic or supine position According to the RzXc graph method of the BIA vector the impedance measurement will be standardized according to the height H of the subject expressing both RzH and XcH in ohmmeters to establish the hydration state Bioelectrical impedance measurements will be assessed twice by the same experienced operator and paired measurements for each patient were used in the analysis
In order to determine GFR the MDRD formula Modification of Diet in Renal Disease involving 4 parameters was deployed It provides an estimate of GFR comparable or superior to other formulae with the advantage of not requiring any anthropometric measurements According to the MDRD GFR can be estimated using the following formula GFR mlmin173m2 175 x serum creatinine mg dL or μmolL884 -1154 x age years -0203 x 0742 if female and 121 if Afro-American The estimating of GFR by means of the MDRD formula is a useful and valid tool with which to obtain an index of kidney function
The echocardiography M B mode color Doppler will be performed with a Vivid 7 echocardiograph with patients in a supine position and slightly left lateral decubitus The mitral flow and the time taken for the wave to return to baseline DTE were evaluated from the apical 4 room positions placing the sample volume of pulsed Doppler at the peak of the valve leaflets during the opening Subsequently the speed of early diastolic movement Ea of mitral annulus obtained from the 4 room projection placing the sample volume of pulsed tissue Doppler onto lateral corner of the annulus was assessed as an index of left ventricular relaxation By measuring the Ea wave and the E Ea ratio the PCWP was evaluated in a quantitative way according to the following formulae
PCWP 124 E Ea 191 for those in sinus rhythm PCWP 0821 E Ea 6489 for those in atrial fibrillation Calculating dpdt The calculating of dpdt was performed by a spectral analysis of mitral regurgitation at CW Doppler Two points were chosen on the mitral regurgitation curve for the correct calculation of echocardiographic dp dt A speed 1 m sec 4 mm Hg and B speed 3 m sec 36 mm Hg The pressure gradient between these two point was reported to be 32 mmHg A - B 36 - 4 32 dPdT was calculated by dividing the pressure gradient between the two points for the temporal distance between them dP dT 32mmHg T msec
Bioelectrical impedance variables will be detected with an impedance plethysmograph using a previously-described methodology 18 This emitted an alternating sinusoidal electric current of 800 mA and an operating single frequency of 50 kHz it which was calibrated each morning using a standard resistor supplied by the manufacturer BIA is a method for detecting whole-body fluid overload and pulmonary congestion based on the theory that the accumulation of whole-body or intrathoracic fluid will conduct an electrical current passing across the body or trunk more easily leading to a decrease in whole-body or pulmonary bioimpedance Bioimpedance is a combination of resistance Rz ie the opposition of an alternating current flowing through intra- and extra-cellular ionic solutions and reactance Xc ie the capacitative component of tissue interfaces cell membranes and organelles As previous described in standard whole-body tetrapolar BIA sensing electrodes were placed on the dorsum of the wrist a line between the radial and ulnar styloid processes the dorsum of the ipsilateral foot and on a line between the medial and lateral malleoli Source electrodes were placed to overlie the head of the third metacarpal on the dorsum of the hand and the third metatarsal on the dorsum of the foot on the same side as the sensing electrodes The measurements will be performed on the right side of the body with the patients in a semi-orthopneic or supine position According to the RzXc graph method of the BIA vector the impedance measurement will be standardized according to the height H of the subject expressing both RzH and XcH in ohmmeters to establish the hydration state Bioelectrical impedance measurements will be assessed twice by the same experienced operator and paired measurements for each patient were used in the analysis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1211 UNIPA-AOUP | OTHER | University of Palermo Policlinico General Hospital | None |