Health TrialsbyHealthPanel

Mechanistic Assessment of Norepinephrine Therapy vs. Angiotensin-II in Septic Shock

ConditionSeptic Shock
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

Despite best therapy efforts, sepsis and septic shock are associated with mortality rates of up to 40%. This clinical trial will determine the benefit of exogenous Angiotensin II versus norepinephrine (conventional care) treatment in septic shock patients. This trial will determine whether there are better predictors of septic shock severity. This approach may inform more appropriate treatment regimens and improve outcomes for these patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Age <18 years

Prisoners

Pregnant women

Patients for whom urgent surgery is anticipated

Trial design

Design model

Parallel

Treatments tested in this trial

  • Angiotensin II

    Drug

    randomized to receive Angiotensin II continuous infusion for up to 48 hours

  • Norepinephrine

    Drug

    randomized to receive Norepinephrine continuous infusion for up to 48 hours

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Angiotensin IIExperimental treatment 1 intervention
Group B: NorepinephrineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean Renin Level - Hour 24

Mean plasma renin level (PRA) as a measure of renin-angiotensin-aldosterone system restoration. Normal levels of active renin \<1.1 pM (40 pg/mL). A level higher than normal can indicate level of shock.

Time frame
Hour 24

Secondary outcomes

1

Norepinephrine Equivalent Dose Requirement (NEE)

NEE indicates severity of shock and need for vasopressors to support blood pressure. Normal range is 0.0-1.0 mcg/kg/min. Levels above normal indicate shock and need for vasopressors. The higher the level the more severe.

Time frame
Baseline, Hour 3, Hour 12, Hour 24, Hour 48, Hour 72
2

Number of Days Without Renal Replacement Therapy

Number of days without renal replacement therapy

Time frame
Day 28
3

Number of Days of Vasopressor Use

Number of days without vasopressor use

Time frame
Day 28
4

Number of Days Without Mechanical Ventilation

Number of days without invasive mechanical ventilation

Time frame
Day 28

Other outcomes

1

Patients with New Deep Venous Thrombosis

Number of patients with development of new deep venous thrombosis

Time frame
Day 7, Day 28
2

Patients with New Pulmonary Embolism

Number of patients with development of new pulmonary embolism

Time frame
Day 7, Day 28
3

Patients with New-Onset Atrial Fibrillation

Number of patients with new-onset atrial fibrillation

Time frame
Hour 72, day 28
4

Patients with New-Onset Ventricular Arrhythmias

Number of patients with new-onset ventricular arrhythmias

Time frame
Hour 72, Day 7, Day 28

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: