AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock
Atslēgvārdi
Abstrakts
Apraksts
Trauma remains the leading cause of death for those under the age of 40 in the United States, with a large percentage of patients dying from blood loss within the initial post-injury hours. Although resuscitation with intravenous fluids and blood products has remained the gold standard over the last twenty years, vigorous volume resuscitation may not be curative and has been associated with the development of serious complications including coagulopathy, acute lung injury, and abdominal compartment syndrome. Massive resuscitation also profoundly alters the neuroendocrine milieu needed to maintain vasomotor tone and these severely injured patients may progress to a state of recalcitrant hypotension, multi-organ failure, and ultimately death. The inclusion of vasoactive hormones during resuscitation could potentially prevent the profound hypotension seen in late stage shock, limit the need for aggressive volume and blood product resuscitation, and decrease the incidence of resuscitation-associated complications. As such, there exists an urgent need to evaluate novel resuscitation strategies that target neuroendocrine deficiencies in hemorrhagic shock. The hormone arginine vasopressin (AVP), in particular, may prove a useful adjunct during resuscitation. Secreted by the posterior pituitary, vasopressin is essential for maintaining vasomotor tone during hemorrhagic shock and low levels are associated with the development of catecholamine-resistant hypotension and profound venodilation. Trauma patients who require more than 5 units of blood products during their initial resuscitation are at risk for developing a vasopressin insufficiency, the need for vasopressor support, and often require longer ICU stays. Vasopressin has enjoyed widespread off-label use as a vasopressor in cardiac arrest, septic shock, and post-cardiopulmonary vasodilatory shock. The central hypothesis is that trauma patients who present in hemorrhagic shock are at risk for vasopressin deficiency and would benefit from early vasopressin supplementation. This study will investigate if early use of vasopressin during the resuscitation of traumatic shock results in fewer blood transfusions, a decreased need for crystalloid resuscitation, and a lower incidence of resuscitation related complications.
Datumi
Pēdējoreiz pārbaudīts: | 03/31/2019 |
Pirmais iesniegtais: | 05/31/2012 |
Paredzētā reģistrācija iesniegta: | 06/03/2012 |
Pirmais izlikts: | 06/04/2012 |
Pēdējais atjauninājums iesniegts: | 04/29/2019 |
Pēdējā atjaunināšana ievietota: | 05/20/2019 |
Pirmo rezultātu iesniegšanas datums: | 01/27/2019 |
Pirmo QC rezultātu iesniegšanas datums: | 04/29/2019 |
Pirmo publicēto rezultātu datums: | 05/20/2019 |
Faktiskais studiju sākuma datums: | 04/30/2013 |
Paredzamais primārās pabeigšanas datums: | 09/05/2016 |
Paredzamais pētījuma pabeigšanas datums: | 09/05/2016 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Drug: Vasopressin
Fāze
Roku grupas
Roka | Iejaukšanās / ārstēšana |
---|---|
Active Comparator: Vasopressin Vasopressin will be given as an initial bolus (4 Units) followed by an infusion titrated between 0 units/min to 0.04 units per min to maintain a mean arterial blood pressure greater than or equal to 65 mmHg | |
Placebo Comparator: Normal Saline An initial bolus of normal saline will be given (10 cc) and an infusion of 0.1 ml per minute will be started and titrated down in as the mean arterial blood pressure reaches 65 mmHg or more. |
Atbilstības kritēriji
Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
Dzimumi, kas ir piemēroti studijām | All |
Pieņem veselīgus brīvprātīgos | Jā |
Kritēriji | Inclusion Criteria: - Trauma patients between the ages of 18 and 65 who require 6 or more units of blood product during their initial 12 hours of resuscitation will be considered for enrollment. Exclusion Criteria: - Patients with a traumatic brain injury requiring neurosurgical operative intervention or who have neurologic trauma deemed non-survivable will also be excluded. - Patients with an active coronary syndrome, history of myocardial infarction or coronary artery disease will be excluded. - Patients with known renal dysfunction requiring dialysis will be excluded. - Patients who are pregnant will be excluded. - Patients less than 18 years old will be excluded. - Patients who have opted out by bracelet identification or by listing themselves on the "Non-Participant" roster. - Patients under the jurisdiction of the department of corrections and considered prisoners prior to the initiation of the research intervention will be excluded |
Rezultāts
Primārie rezultāti
1. Number of Blood Products Transfused [48 hours following the initiation of therapy]
Sekundārie iznākuma mērījumi
1. Need for Vasopressor Requirement Vasopressor Requirement [48 hours following the initiation of therapy]
2. Total Number of Complications [30 days post injury]