Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Giapreza is a synthetic human Ang II treatment which acts as a RAAS pathway regulator to rais MAP in adults. This will be a single center study comparing patients treated with a modified Emory protocol to historical controls who have not received Ang II. We will observe the effects of using a modified version of the Emory protocol, which includes lowering the dosages needed for norepinephrine and vasopressin. Additionally, clinicians will administer Ang II prior to starting methylene blue, a drug that poses more risk to patients than Ang II. Using this modified version of this protocol, 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. If patients do not achieve their MAP goal of 65mmHg or greater within 3 hours, then they will have ANG II discontinued and will receive a dose of methylene blue at 2 mg/kg. If the patients do not achieve their MAP goal with methylene blue then they will receive a cyanokit.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ang II Administration using a modified Emory protocol | Experimental | Using this modified version of this protocol, 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. Case report forms (CRF) tracking MAP and dosage of drugs will be completed for each patient for up to 48 hours. |
|
| Evaluating Effectiveness of modified Emory Protocol on outcomes from vasoplegia after bypass | No Intervention | Historical controls will be extracted from EMR and selected based on 1:1 matching with patients in experimental arm. Matching will be based on a number of factors. Descriptive and comparative analyses will be conducted. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | in-hospital or post-hospital mortality within 1 year | 365 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure | Changes in Mean Arterial Pressure | Hours 3, 6, 9, 12, 24 and 48, |
| Length of Stay | ICU | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Re-admission | Re-admission to hospital for related event | 1 year |
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32019600 | Background | Busse LW, Barker N, Petersen C. Vasoplegic syndrome following cardiothoracic surgery-review of pathophysiology and update of treatment options. Crit Care. 2020 Feb 4;24(1):36. doi: 10.1186/s13054-020-2743-8. | |
| 35783549 | Background | Ten Lohuis CC, Burke SC, Jannuzzo CJ, Barker NA, Chen EP, Busse LW. Protocol Compliance Guiding Angiotensin II Use in Post Cardiovascular Surgery Vasoplegia. Crit Care Explor. 2022 May 13;4(5):e0687. doi: 10.1097/CCE.0000000000000687. eCollection 2022 May. |
| Label | URL |
|---|---|
| Giapreza drug information and package insert | View source |
Not provided
Individual participant data that underlie the results reported in any article, after deidentification (text,tables, figures, and appendices).
Beginning 9 months after and ending 36 months following any article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Not provided
Not provided
| ID | Term |
|---|---|
| D056987 | Vasoplegia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D000804 | Angiotensin II |
| C000627694 | Giapreza |
| ID | Term |
|---|---|
| D000809 | Angiotensins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Length of Stay | In Hospital, post ICU | 1 year |
| 28528561 | Background | Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21. |
| Giapreza drug information | View source |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |