Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Change in plasma volume |
Assessed using weight and HCT |
A week after 1st visit |
|
Other |
Change in plasma volume |
Assessed using weight and HCT |
2 weeks after 1st visit |
|
Other |
Change in plasma volume |
Assessed using weight and HCT |
3 weeks after 1st visit |
|
Other |
Rate of magnesium deficiency a week after treatment |
Defined as Mag levels <1.6mmol/dl |
A week after 1st visit |
|
Other |
Rate of magnesium deficiency a week after treatment |
Defined as Mag levels <1.6mmol/dl |
2 weeks after 1st visit |
|
Other |
Rate of magnesium deficiency a week after treatment |
Defined as Mag levels <1.6mmol/dl |
3 weeks after 1st visit |
|
Other |
Change in body weight a week after each IV regimen |
weight scale |
A week after 1st visit |
|
Other |
Change in body weight a week after each IV regimen |
weight scale |
2 weeks after 1st visit |
|
Other |
Change in body weight a week after each IV regimen |
weight scale |
3 weeks after 1st visit |
|
Other |
Change in BNP level a week after each IV treatment |
Plasma Nt-ProBNP |
A week after 1st visit |
|
Other |
Change in BNP level a week after each IV treatment |
Plasma Nt-ProBNP |
2 weeks after 1st visit |
|
Other |
Change in BNP level a week after each IV treatment |
Plasma Nt-ProBNP |
3 weeks after 1st visit |
|
Other |
Change in decongestion achieved by change in congestion score- week after treatment |
A composite score of: pedal edema, orthopnea, ultrasound evidence of pleural effusion, ascites and B-lines. each getting a rank between 0-4. total score can range from 0-16, where higher score indicates worse congestion and prognosis status. |
A week after 1st visit |
|
Other |
Change in decongestion achieved by change in congestion score- week after treatment |
A composite score of: pedal edema, orthopnea, ultrasound evidence of pleural effusion, ascites and B-lines. each getting a rank between 0-4. total score can range from 0-16, where higher score indicates worse congestion and prognosis status. |
2 weeks after 1st visit |
|
Other |
Change in decongestion achieved by change in congestion score- week after treatment |
A composite score of: pedal edema, orthopnea, ultrasound evidence of pleural effusion, ascites and B-lines. each getting a rank between 0-4. total score can range from 0-16, where higher score indicates worse congestion and prognosis status. |
3 weeks after 1st visit |
|
Primary |
Sodium weight |
Na Weight (Spot Na * total volume of urine) |
1st week visit (time zero) |
|
Primary |
Sodium weight |
Na Weight (Spot Na * total volume of urine) |
1 week after 1st visit |
|
Primary |
Sodium weight |
Na Weight (Spot Na * total volume of urine) |
2 weeks after 1st visit |
|
Secondary |
Urine Volume |
Total urinary volume starting from initiation of intravenous (IV) therapy for 6 hours |
1st week visit (time zero) |
|
Secondary |
Urine Volume |
Total urinary volume starting from initiation of intravenous (IV) therapy for 6 hours |
1 week after 1st visit |
|
Secondary |
Urine Volume |
Total urinary volume starting from initiation of intravenous (IV) therapy for 6 hours |
2 weeks after 1st visit |
|
Secondary |
Rate of symptomatic hypotension events |
Systolic BP <90mmhg with symptoms |
A week after 1st visit |
|
Secondary |
Rate of symptomatic hypotension events |
Systolic BP <90mmhg with symptoms |
2 weeks after 1st visit |
|
Secondary |
Rate of symptomatic hypotension events |
Systolic BP <90mmhg with symptoms |
3 weeks after 1st visit |
|
Secondary |
rate of worsening renal function events |
WRF defined as a >0.3 mg/dL increase in serum Cr, or a >20% decrease in eGFR by the CKDEPI formula |
A week after 1st visit |
|
Secondary |
rate of worsening renal function events |
WRF defined as a >0.3 mg/dL increase in serum Cr, or a >20% decrease in eGFR by the CKDEPI formula |
2 weeks After 1st visit |
|
Secondary |
rate of worsening renal function events |
WRF defined as a >0.3 mg/dL increase in serum Cr, or a >20% decrease in eGFR by the CKDEPI formula |
3 weeks after 1st visit |
|
Secondary |
Rate of hyponatremia during treatment phase |
Hyponatremia <133mmol/dl |
A week after 1st visit |
|
Secondary |
Rate of hyponatremia during treatment phase |
Hyponatremia <133mmol/dl |
2 weeks after 1st visit |
|
Secondary |
Rate of hyponatremia during treatment phase |
Hyponatremia <133mmol/dl |
3 weeks after 1st visit |
|
Secondary |
Rate of dyskalemia events during treatment phase |
Dyskalemia defined as <3.5 or >5.6mmol/dl |
A week after 1st visit |
|
Secondary |
Rate of dyskalemia events during treatment phase |
Dyskalemia defined as <3.5 or >5.6mmol/dl |
2 weeks after 1st visit |
|
Secondary |
Rate of dyskalemia events during treatment phase |
Dyskalemia defined as <3.5 or >5.6mmol/dl |
3 weeks after 1st visit |
|
Secondary |
Rate of metabolic acidosis events requiring NaHCO3 supplements |
Rate of Metabolic acidosis (requiring NaHCO3 supplements) events |
A week after 1st visit |
|
Secondary |
Rate of metabolic acidosis events requiring NaHCO3 supplements |
Rate of Metabolic acidosis (requiring NaHCO3 supplements) events |
2 weeks after 1st visit |
|
Secondary |
Rate of metabolic acidosis events requiring NaHCO3 supplements |
Rate of Metabolic acidosis (requiring NaHCO3 supplements) events |
3 weeks after 1st visit |
|