The New England Journal of Medicine February 28, 2008

Vasopressin versus Norepinephrine Infusion in Patients with Septic Shock

James A. Russell, Keith R. Walley, Joel Singer, Anthony C. Gordon, Paul C. Hébert, D. James Cooper et al. (VASST Investigators)

Bottom Line

In a multicenter randomized trial of patients with septic shock, the addition of low-dose vasopressin to norepinephrine did not significantly reduce 28-day mortality compared to norepinephrine alone.

Key Findings

1. Overall 28-day mortality was not significantly different between the vasopressin and norepinephrine groups (35.4% vs. 39.3%, respectively; P=0.26) [2.1.1].
2. There was no significant difference in 90-day mortality between the vasopressin and norepinephrine groups (43.9% vs. 49.6%, respectively; P=0.11).
3. No significant difference was observed in the overall rates of serious adverse events between the two groups (10.3% vs. 10.5%; P=1.00).
4. In a prospectively defined stratum of less severe septic shock (baseline norepinephrine 5-14 mcg/min), vasopressin was associated with a lower 28-day mortality (26.5% vs. 35.7%, P=0.05), though the test for heterogeneity between the strata was not significant (P=0.10).

Study Design

Design
RCT
Double-Blind
Sample
778
Patients
Duration
28 days
Median
Setting
Multicenter, multinational
Population Adult patients with established septic shock who were receiving a minimum of 5 mcg per minute of norepinephrine for at least 6 hours.
Intervention Low-dose vasopressin (0.01 to 0.03 U/min) administered in addition to open-label vasopressors.
Comparator Norepinephrine (5 to 15 mcg/min) administered in addition to open-label vasopressors.
Outcome Mortality rate 28 days after the start of infusions.

Study Limitations

The trial was originally powered to detect a highly ambitious 10% absolute mortality difference based on an expected baseline mortality of 60%, whereas the observed mortality was approximately 40%, leaving the trial potentially underpowered to detect a smaller but clinically meaningful survival benefit [2.1.2].
The finding of reduced mortality in the 'less severe shock' subgroup is hypothesis-generating, as the formal statistical test for heterogeneity between the strata was not significant.
Both treatment arms required ongoing open-label titration of background vasopressors, which may have blurred the distinctions between the physiologic effects of the randomized treatments.

Clinical Significance

The VASST trial established that low-dose vasopressin does not provide an overall survival advantage when used as a primary adjunct in established septic shock compared to norepinephrine. However, it confirmed the safety and catecholamine-sparing effect of vasopressin. Today, vasopressin is widely utilized as a second-line adjunctive vasopressor to reduce high catecholamine requirements rather than to directly improve mortality.

Historical Context

Prior to VASST, it was widely recognized that established septic shock is characterized by a relative deficiency of endogenous vasopressin. Smaller preliminary studies had suggested that exogenous vasopressin administration could robustly restore mean arterial pressure and reduce the need for high-dose catecholamines, which were known to carry risks of ischemia and arrhythmias. The VASST trial was a highly anticipated, landmark study designed to test whether this potent physiologic and catecholamine-sparing effect would translate into a tangible survival benefit. Its neutral primary outcome profoundly shaped subsequent Surviving Sepsis Campaign guidelines, solidifying vasopressin's role as a secondary adjunctive agent rather than a first-line alternative.

Guided Discussion

High-yield insights from every perspective

Med Student
Medical Student

Based on the pathophysiology of septic shock, what is the rationale for adding vasopressin, a non-adrenergic vasopressor, to a patient already receiving norepinephrine?

Key Response

Septic shock is characterized by profound vasodilation and relative vasopressin deficiency. Vasopressin acts on V1 receptors on vascular smooth muscle to cause vasoconstriction independent of alpha-1 adrenergic receptors, sparing the heart from excessive chronotropic and inotropic effects associated with escalating catecholamine doses.

Resident
Resident

In managing a patient with septic shock whose mean arterial pressure remains below 65 mm Hg despite adequate fluid resuscitation and a norepinephrine infusion, at what dose threshold of norepinephrine should you typically consider adding vasopressin according to the VASST trials practical implications?

Key Response

While VASST showed no overall mortality difference, it highlighted the safety of adding low-dose vasopressin (up to 0.03 U/min). Clinically, this translates to adding vasopressin early-to-mid course, often when norepinephrine requirements reach escalating levels (e.g., 0.25 to 0.5 mcg/kg/min), to achieve catecholamine-sparing effects and prevent refractory shock.

Fellow
Fellow

The VASST trial identified a potential mortality benefit in the less severe septic shock stratum (baseline norepinephrine less than 15 mcg/min). How does this subgroup finding influence your hemodynamic management strategy, and what are the physiologic risks of starting vasopressin too late in refractory shock?

Key Response

The subgroup analysis suggested that starting vasopressin before catecholamine requirements become extreme might be beneficial by mitigating prolonged adrenergic toxicity. Starting it too late in severe shock might be futile due to established irreversible microvascular dysfunction, profound acidosis blunting receptor responsiveness, and the risk of ischemic complications in profoundly compromised vascular beds.

Attending
Attending

Given that VASST demonstrated no overall mortality benefit but confirmed a catecholamine-sparing effect, how do you weigh the cost and potential adverse effects of vasopressin against the known toxicities of high-dose norepinephrine when individualizing a dual-vasopressor strategy?

Key Response

The key teaching point is individualized therapy. Physicians must recognize when a patient is experiencing catecholamine toxicity, such as severe tachyarrhythmias, and use vasopressin as a sparing agent. This decision balances mitigating adrenergic toxicity against the risk of vasopressin-induced profound vasoconstriction in vulnerable splanchnic or digital beds, requiring careful bedside assessment of perfusion.

Scholarly Review

Critical appraisal through the lens of expert reviewers and guideline development

PhD
PhD

The VASST trial utilized an unadjusted subgroup analysis based on baseline norepinephrine dose severity, which yielded a nominally significant P-value for the less severe shock stratum. What are the statistical limitations of this a priori subgroup analysis, and how should a future trial be designed to definitively test this hypothesis?

Key Response

Subgroup analyses, even when predefined, are prone to Type I errors due to multiple testing and reduced power. Furthermore, the VASST test for interaction between treatment and severity stratum was not statistically significant (P=0.10). A definitive trial must be prospectively powered for this specific early vs late population as the primary endpoint.

Journal Editor
Journal Editor

As a reviewer evaluating the VASST trial, how does the allowance of open-label vasopressors by treating physicians introduce a potential co-intervention bias that could mask a true treatment effect of vasopressin?

Key Response

In a trial titrating blinded study drug against open-label norepinephrine to a MAP target, physicians unblinded to the overall clinical trajectory might rapidly escalate open-label catecholamines based on bedside bias. This could blur the physiologic separation between groups, minimizing the detectable difference in 28-day mortality and threatening the trials internal validity.

Guideline Committee
Guideline Committee

How does the VASST trial inform the Surviving Sepsis Campaign guidelines regarding the strength of recommendation for adding vasopressin, and does the evidence justify its use as a first-line agent or purely as an adjunct?

Key Response

The Surviving Sepsis Campaign guidelines recommend adding vasopressin (up to 0.03 U/min) to norepinephrine with the intent of raising MAP to target or decreasing norepinephrine dosage (Weak recommendation, moderate-quality evidence). Because VASST showed no mortality superiority over norepinephrine alone but established its safety as a catecholamine-sparing agent, guidelines firmly position it as a second-line adjunct.

Clinical Landscape

Noteworthy Related Trials

2010

SOAP II Trial

n = 1,679 · NEJM

Tested

Dopamine

Population

Patients with shock requiring vasopressors

Comparator

Norepinephrine

Endpoint

28-day mortality

Key result: There was no significant difference in 28-day mortality, but dopamine was associated with significantly more arrhythmic events.
2014

SEPSISPAM Trial

n = 776 · NEJM

Tested

High MAP target (80 to 85 mm Hg)

Population

Patients with septic shock requiring vasopressors

Comparator

Low MAP target (65 to 70 mm Hg)

Endpoint

28-day mortality

Key result: Targeting a higher MAP did not reduce 28-day mortality compared to a lower target, though it reduced the need for renal replacement therapy in patients with chronic hypertension.
2016

VANISH Trial

n = 409 · JAMA

Tested

Early vasopressin infusion

Population

Patients with septic shock

Comparator

Norepinephrine infusion

Endpoint

Kidney failure-free days at 28 days

Key result: Early use of vasopressin did not significantly improve the number of kidney failure-free days compared to norepinephrine.

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