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Rivers trial

Best practices on how to use simple flash animations in combination with prezi Path and Frames - to achieve a strong narrative.

Sarah Jarrold

on 18 October 2012

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Transcript of Rivers trial

"Golden Hours" This study focuses on the use of definate resus strategies, applied early
--> goal orientated manipulation of cardiac preload, afterload, contractility

--> Balance between O2 demand and delivery
using RESUSITATION end points previous studie have suggested
early HD assessment
- physical findings, vital signs, CVP, UO
--> fail to detect persistant global tissue hypoxia Aim: Evaluate the efficacy of early goal-directed treatment before admisison to ICU in reducing incidence of MODS, mortality and the use of health care resources.
Recruitment of pts through urban ED
- severe sepsis
- septic shock Early Goal Directed Therapy in the Treatment of Severe Sepsis and Septic Shock Systemic inflammatory response system
- self limiting <--> shock/ multiorgan failure /death RESULTS Systemic Oxygen
Delivery Oxygen
Demand Circulation abnormalities
- intravascular volume depletion
- peripheral vasodilation
- myocardial depression
- increased metabolism <- Global tissue hypoxia ->
<- acitivation of inflammatory cascade->
<- endothelial activation <-> disturbance coagulation, vascular permeability, vasclar tone->
<- shock ->
<- multiorgan failure ->
<- death -> which can lead to irrecoverable shock, organ failure, death The New England Journal of Medicine, 2001 Emanuel Rivers, M.D.,M.P.H., Bryant Ngyugen, M.D., Suzanne Havstad, M.A., Julie Ressler, B.S., Alexandria Muzzin, B.S., Bernhard Knoblich, M.D., Edward Peterson, Ph.D., and Michael Tomlanovich, M.D., For the early goal-directed therapy collabortaive group The transition to serious illness occurs
during the critical "golden hours"
when definative recognition and treatment provide maximal benefit in terms of outcome these initial hrs may elapse in WR, ED, ICU, ward mixed venous oxygen saturations
(ideally pulomary artery cathetor/usu CVL)
arterial lactate
base deficit
pH METHODS Eligibility
--> >18 yrs presenting to ED of 850-bed tertiary hospital
--> March 1997 - March 2000 INCLUSION
sys BP <= 90mmHg
(post 20-30mls/kg crystalloid bolus)
OR lacate > 4mmol/L
AND 2/4 SIRS criteriae SIRS criteriae
1. temp > 38C OR < 36C
2. HR > 90
3. RR > 20 OR paCO2 < 32 mmHG
4. WCC > 12 or < 4 OR
> 10% immature band cells EXCLUSION
< 18 yrs
acute CVA
status asthmaticus
cardiac dysrythmia
active GI bleed
drug overdose
burn injury
need for immediate surgery
NFR Prospective, randomised (computer generated) study FIGURE 1: Overview of pt enrollment and HD support tx at clinicians discretion CVL inserted able to measure cVO2 sats tx for at least 6 hrs - transferred to 1st available ICU bed ED aware of tx arms
ICU not aware 500mls bolus crystalloid q30mins if MAP < 65 --> vasopressors
if MAP > 90 --> vasodilators dobutamine added - 2.5 mcg/kg/min
increased by 2.5mcg q30mins
max 20mcg/kg/min
(reduced if MAP < 65/HR > 120) Figure 2: Protocol for Early-Goal Directed therapy Outcome measurements
--> continuously monitored for 6 hrs
--> q12th hrly for 72 hrs
ABG, VBG (cV O2sats)
coag-related variables determine
APACHE 11 score
simplified acute phsyioogy score
MODS score

Baseline, 3,6,12,24,36,48,60,72 hrs Followed for 60 days or until death
also looked at consumption of health care resources End points
PRIMARY - in-hospital mortality
SECONDARY - resus end points, organ-dysfuciton scores, caogulation related variables, adminstered treatments, consumptions of heatth-care resources ANALYSIS: calculated a sample size of 260 rquired, P-value < 0.04 required for statistical significance,
differences between the two groups calculated using students t-test or chi-square test, or wilcoxonsons test 288 pts evaluated, 263 admitted
8.7% (25 pts) excluded/did not consent
236 completed 6hr tx period
27 discontinued (14 St Tx/ 14 EGD Tx)
100% examined in intention-to-treat
(included data only those who completed the 6 hrs Tx however stated no difference in baseline characteristics or baseline evaluations)
no difference in baseline characteristics
including adequacy and duration of antibiotics
vital signs, resus end points, organ-dysfunciton scores, coag related variables - similar in both groups (table 2) both > 65 0-6hrs period
combined HD goals for CVP, MAP, UO acheived in 86.1% standard Tx, 99.2% EGDTx
standard Tx - lower cv O2 sats, greater Base deficit, similar lactate and pH similar CVP + - + - - + + - + + + + + + MORTALITY + + + + = PICU teaching
Sarah Jarrold
18th October 2012 Early Goal-directed therapy in the treatment of severe spesis and septic shock Treatments administered 1st 6 hrs
more fluid, more RBC, more ionotopic support in EDGT group
similar rates of vasopressors and IPPV

7-72 hrs
more fluid, more RBCS, more vasopressors, more pulm artery cathtors, more IPPV in standard Tx group
similar ionotropes 0-72 hrs
no differnce in volume of fluid, use of ionotropes
higher use of vasopressors, IPPV, pulm-art cathetor in standard grp, lower RBCS used with lower haematocrit DISCUSION Significant benefits with respect to outcome when goal directed Tx applied earlier.
mortality due to sudden CV collapse double in standard Tx group
--> abrupt transition to severe disease
--> therefore imp to identify pts with insiduous illness (gobal tissue hypoxia with stable vital signs)
If initial tx not comprehensive, the progression to severe disease well established by admission to ICU (unsalvagable) Problems with trial Open, randomised, partially blinded trial
--> unavoidable interactions in initial part of trial
--> pts in standard Tx receiving the treatment from EGDTx as same clinicians treating them TAKE HOME MESSAGE Treat early and treat aggressively to prevent progression to an irreversible state

consideration should be given to initiating goal-directed therapy, using invasive monitoring, as early as possible in patients who present with severe sepsis -- especially where transfer to the ICU does not occur immediately ARR of 16%
NNT 6.25
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