aldosterone and Hypoproteinemia

aldosterone has been researched along with Hypoproteinemia in 2 studies

Hypoproteinemia: A condition in which total serum protein level is below the normal range. Hypoproteinemia can be caused by protein malabsorption in the gastrointestinal tract, EDEMA, or PROTEINURIA.

Research

Studies (2)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

1a. Time to Administration of the First Dose of Study Drug

This objective is a measure of protocol adherence. The goal is to have patients randomized within 6 hours, and study drug administration completed within 8 hours of starting a vasoactive medication. We will consider adherence to our protocol to be adequate if secondary outcomes 1a to 1c are met in 80% of enrolled patients. (NCT02044159)
Timeframe: 8 hours from starting vasoactive medication

1b. Weaning of Study Drug to q8h When Patient is Hemodynamically Stable

This objective is a measure of protocol adherence. The goal is weaning of study drug to q8h within 12 hours of no escalation of therapy. We will consider adherence to our protocol to be adequate if secondary outcomes 1a to 1c are met in 80% of enrolled patients. (NCT02044159)
Timeframe: 7 days

1c. Discontinuation of Study Drug When Off All Vasoactive Medications

This objective is a measure of protocol adherence. The goal is to discontinue study drug within 12 to 18 hours of vasoactive medications being stopped. We will consider adherence to the protocol adequate if secondary outcomes 1a to 1c are met in 80% of enrolled patients. (NCT02044159)
Timeframe: 7 days

Number of Participants With Incidence of Adverse Events and Mortality in the Full Cohort

The specific adverse events that will be measured include: severe bleeding, secondary infections and the use of insulin infusions. The incidence of adverse events and mortality rate was measured in aggregate (i.e. the whole cohort) in order to provide a better baseline estimate of these outcomes in our study population. (NCT02044159)
Timeframe: Daily during hospital admission (up to 28 days)

Number of Patients Started on Open Label Steroids by the Treating Physician

We will consider the number of patients started on open label steroids by the treating physician to be acceptable if it occurs in less than 10% of patients. We will also collect information on the clinical parameters of patients when open label steroids are given. (NCT02044159)
Timeframe: 7 days

Patient Accrual Rate Over One Year (% of Target Sample Size Achieved)

The total number of participants recruited over the recruitment period to both arms (this was a feasibility outcome that was analyzed for the full cohort and, as stated a priori in the study protocol was not compared between study arms). Our goal is to recruit 72 patients over one year . However, we will consider patient accrual rate to be adequate if we recruit 60 patients from seven sites within this time period. (NCT02044159)
Timeframe: 1 year

Percentage of Patients for Whom Blood Samples Are Sent, and Successfully Received and Analyzed in Their Respective Labs

A total of 3 ml of blood in a red top tube will be collected within 24 hours of hospital admission. Patients with access for blood sampling and for whom consent has been obtained will have blood samples collected. The samples will be separated at each centre, stored until the end of the recruitment period, and then shipped to the principal investigators's centre as per the specific test requirements. The free cortisol and stratification biomarker samples will be batched and then shipped to Cincinnati for analysis at the end of the study. The number of samples collected, and the number of samples successfully received and analyzed at the principal investigator's site and at the Cincinnati lab will be determined at the end of the recruitment phase. (NCT02044159)
Timeframe: End of the study recruitment phase (up to 1.5 years)

Time to Discontinuation of Vasoactive Infusions

The time to discontinuation of vasoactive agents will be used to better estimate the sample size for the full study. (NCT02044159)
Timeframe: Daily during hospital admission (up to 28 days)

Other Studies

2 other studies available for aldosterone and Hypoproteinemia