aldosterone and Critical Illness

aldosterone has been researched along with Critical Illness in 13 studies

Critical Illness: A disease or state in which death is possible or imminent.

Research

Studies (13)

Authors

Clinical Trials (6)

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)

Hemodynamics as Characterized by Mean Arterial Pressure

Organ perfusion pressure measured as Mean Arterial Pressure (MAP). It will be measured hourly for 24 postoperative hours for all subjects and compared between the two study groups over the whole time of observation as the main between-group effect in panel regression. (NCT03088345)
Timeframe: 24 hours post-operative

Hemodynamics as Characterized by Transpulmonary Pressure Gradient

The transpulmonary pressure gradient (TPG), defined as the difference between mean pulmonary arterial pressure (Ppa) and left/common atrial (common atrial) pressure (Pla) will be measured hourly for 24 postoperative hours for all subjects and compared between the two study groups over the whole time of observation as the main between-group effect in panel regression. (NCT03088345)
Timeframe: 24 hours post-operative

Hemodynamics as Characterized by Vasoactive Inotrope Score (VIS)

The vasoactive inotrope score (VIS) is a linear sum of vasoactive and inotrope durg infusion doses. It is usually reported as dimensionless but is sometimes reported as normalized to dopamine mcg/kg/min equivalents. The score starts at 0 and has no defined upper limit, with a commonly observed range 0-50. It is used as a measure of the intensity of hemodynamic support, with higher scores indicating more vasoactive drug support for patients. The relationship of VIS to other patient outcomes is not consistent. It will be calculated hourly for all subjects and compared between groups over the entire observation timeframe. (NCT03088345)
Timeframe: 48 hours post-operative

Liver Dysfunction as Characterized by Transaminase Levels

Transaminase levels (alanine and aspartate, measured in IU/L ) will be tracked for all patients and changes will be compared between study groups. (NCT03088345)
Timeframe: 48 hours post-operative

Renal Dysfunction as Characterized by Change in Cystatin Level

Cystatin levels will be measured at baseline (immediately before cardiopulmonary bypass) 24 hours postoperative. The change (postoperative minus baseline) in cystatin level will be compared between groups. (NCT03088345)
Timeframe: from baseline pre-cardiopulmonary bypass to 24 hours post-operative

Resource Utilization Measured by Length of Stay (LOS)

Length of stay (LOS) measured in postoperative hours compared between groups (NCT03088345)
Timeframe: from time of operation until hospital discharge

Reviews

2 reviews available for aldosterone and Critical Illness

Trials

2 trials available for aldosterone and Critical Illness

Other Studies

9 other studies available for aldosterone and Critical Illness