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© SICS EBM Group 2004
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Low Dose Vasopressin in Septic Shock
Three-part Clinical Question: 1. Patients: Septic shock. 2. Intevention: the addition of low dose vasopressin compared to the use of catecholamines alone.
3.
Outcomes: Death Search Terms: Septic shock, Intervention, RCT, Vasopressin, Norepinephrine.
The Study:Double-blinded randomised controlled trial with intention-to-treat.
All patients: Unlabelled “study-drug” to reach a target MAP of 65-75mmHg. Open-label vasopressors were also used to reach/maintain target MAP during and after study drug titration (The open-label vasopressor were increased only is the target MAP was not reached on maximal study-drug infusion). Standard ITU care of the septic patient was also given. The study-drug was continued for as long as required unless predetermined adverse events occurred (cardiac events, organ/tissue ischaemia etc).
The Evidence:
EBM questions:
1) Do the methods allow adequate testing of the hypothesis? To an extent, but may have been inadequately powered.
2) Do the statistical tests used correctly test the results to allow differentiation of statistically significant findings? Yes, the statistics used are appropriate, however the mortality rate was much lower than predicted by investigators (~34& v 60%). This may have resulted in an inadequately powered study.
3) Are conclusions valid in light of results? Yes, there is no evidence from this RCT to support the use of vasopressin in preference to norepinephrine for septic shock.
4) Did results get omitted and why? Yes. 1 patient in the vasopressin arm was lost to follow-up.
5) Did they suggest further areas of research? Yes, suggested future trials looking at vasopressin in "less severe" septic shock.
6) Did they make recommendations and are these appropriate? No .
7) Is this study relevant to my clinical practise? Althought this is a well designed RCT it does not address catecholamine-refractory septic shock - a setting where vasopressin is more commonly used. Important patient groups such as those with cardiac disease/ACS were excluded from the trial and as such we are unable to assess how common adverse events would have been in these groups.
8) What level of evidence does this represent? 1+
9) What grade of recommendation can I make on this alone? B
10) What grade of recommendation can I make when this study is considered along with other available evidence? B
11) Should I change my practice in light of this study? Possibly not - Vasopressin is commonly used in catecholamine-refractory shock, which is not fully addressed by this RCT.
12) Should I audit my practice because of this paper? No
Appraised by: Dr Robert Docking, ST2 Anaesthetics, Inverclyde Royal Hospital,
Greenock, PA16 OXN , Dr Kevin Rooney, Consultant in Anaesthetics and Intensive
Care, Royal Alexandra Hospital, Paisley, PA2 9PN
©SICS EBMG 2009
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