Health TrialsbyHealthPanel

Angiotensin II for Post Cardiac Surgery Vasoplegia (ANGII_V)

ConditionsVasoplegic ShockCardiopulmonary BypassVasoplegia
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-94
SponsorMethodist Healthcare System of San Antonio

About this trial

The goal of this study is to conduct a prospective trial implementing a modified version of the Emory Protocol for administering ANG II to patients with post cardiac bypass vasoplegia. The main questions we aim to answer are: 1.) does administration of improve mortality, 2.) does the administration of Ang II using the modified protocol shorten the time needed to reach optimal MAP, 3.) does the administration of Ang II using the modified protocol shorten length of stay in the ICU and hospital? Researchers will compare outcomes from the interventional group to historical controls who did not receive Ang II using the modified protocol.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, aged 18 or over

Exhibiting vasoplegia or vasoplegic shock following surgeries involving cardiopulmonary bypass

Disqualifiers

Current use of angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs)

Presence of treatment with high-dose glucocorticoids

Pregnancy or lactation

Known allergic reactions to components of the Giapreza, <specify components/allergens>

Trial design

Design model

Parallel

Treatments tested in this trial

  • Angiotensin II (Giapreza®)

    Drug

    Patients who have post cardiopulmonary bypass vasoplegia who are already on vasopressin 0.04 units/min, norepinephrine 0.1 mcg/kg/min will have Ang II initiated at 10 to 20 ng/kg/min and titrated by 10 ng/kg/min every 5 minutes to a maximum dose of 80 ng/kg/min.

Treatment groups

329 Participants
are divided into 2 treatment groups
Group A: Ang II Administration using a modified Emory protocolExperimental treatment 1 intervention
Group B: Evaluating Effectiveness of modified Emory Protocol on outcomes from vasoplegia after bypassNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Mortality

in-hospital or post-hospital mortality within 1 year

Time frame
365 days

Secondary outcomes

1

Mean Arterial Pressure

Changes in Mean Arterial Pressure

Time frame
Hours 3, 6, 9, 12, 24 and 48,
2

Length of Stay

ICU

Time frame
1 year
3

Length of Stay

In Hospital, post ICU

Time frame
1 year

Other outcomes

1

Re-admission

Re-admission to hospital for related event

Time frame
1 year

Locations

This trial has no locations.

Sponsors and contacts

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

Methodist Healthcare System of San Antonio

Lead sponsor

Source ClinicalTrials.gov

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