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Early goal-directed therapy after major surgery reduces complications and
duration of hospital stay.
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Early post-operative goal-directed
therapy in major general surgery is associated with a reduction in post
operative complications and duration of hospital stay.
Level of evidence: 1+
(RCT with low risk of bias) |
Citations: Pearse et
al. Early goal-directed therapy after major surgery reduces complications and
duration of hospital stay. A randomised, controlled trial. Critical Care 2005,
9:R687-R693
Lead author's name and fax: Dr Rupert Pearse, rupert.pearse@doctors.net.uk
Three-part Clinical Question: patients= major general surgery;
intervention=post operative goal directed therapy; outcome=complications, length
of hospital stay
Search Terms: "goal-directed therapy" and “major surgery" in PubMed
The Study: Single-blinded randomised controlled trial with
intention-to-treat.
The Study Patients: 18yrs or older undergoing major general surgery
expected to last more than 90 minutes and deemed to be at high risk of
developing post operative complications. Exclusion criteria: Pregnancy, acute
myocardial ischaemia, palliative treatment, disseminated malignancy, those
unlikely to survive more than six hours , those requiring intervention outside
ITU in the first six hours, patients on lithium, wt less 40kg. All patients had
their cardiac output measured with the LiDCO plus system (LiDCO Ltd, Cambridge,
UK). Clinicians were blinded to these measurements until predefined conditions
were met (see below). All patients were managed by the trial protocol for the
first 8 hours in ICU, after which time all care decisions were taken by the
clinical staff.
Control group (N = 60; 60 analysed): Fluid challenges using 250ml boluses
of colloid solution until a sustained rise in CVP achieved for 20 minutes. If
urine output fell or serum lactate increased despite this the cardiac output was
revealed to the clinicians. If cardiac index found to be <2.5ml min-1m-2 epinephrine
was commenced.
Experimental group (N = 62; 62 analysed): Fluid challenges using 250ml
boluses of colloid solution until a sustained 10% rise in stroke volume was
achieved. If DO2I <600 ml per minute per m2 dopexamine
was commenced until target DO2I was reached. If urine output fell or
serum lactate increased despite this, cardiac output was revealed to the
clinicians. If cardiac index found to be <2.5ml min-1m-2 epinephrine
was commenced.
The Evidence:
|
Outcome |
Time to Outcome |
CER |
EER |
RRR |
ARR |
NNT |
|
Complications |
60 DAYS |
0.683 |
0.435 |
36% |
0.248 |
4 |
|
95% Confidence Intervals: |
11% to 61% |
0.077 to 0.419 |
2 to 13 |
Complications defined as: Infection, respiratory, cardiovascular, abdominal or
haemorrhage.
|
Non-Event Outcomes |
Time to outcome/s |
Control group |
Experimental group |
P-value |
|
Mean duration of hospital stay |
60 DAYS |
29.5 |
17.5 |
0.001 |
|
Median duration of hospital stay |
60 DAYS |
14 (11-27) |
11 (7-15) |
0.001 |
|
Mortality |
60 DAYS |
9 |
7 |
0.59 |
EBM questions:
1. Do the methods allow accurate testing of the hypothesis? Yes.
2. Do the statistical tests correctly test the results to allow differentiation
of statistically significant results? Yes.
3. Are conclusions valid in light of the results? Yes.
4. Did results get omitted, and why? No.
5. Did they suggest areas of further research? Yes. The authors
recommended a large multicentre trial should be performed to validate the
applicability of these findings on a wider population.
6. Did they make any recommendations based on the results and were they
appropriate? No.
7. Is the study relevant to my clinical practice? Yes.
8. What level of evidence does
this study represent? 1+
9. What grade of recommendation
can I make on this result alone? B.
10. What grade of recommendation
can I make when this study is considered along with other available evidence?
None- no similar studies of post-operative GDT in high risk patients undergoing
major general surgery were found.
11. Should I change my practice because of these results? Probably, given
that this study offers an inexpensive and safe way of reducing postoperative
complications and duration of hospital stay. From this study it seems that the
beneficial effects of GDT may be achieved whilst avoiding the logistical
difficulties of pre-operative ICU admission.
12. Should I audit my current practice because of these results? Yes.
Appraised by: Dr David Elliott SpR Anaesthesia
Dept Of Anaesthesia Royal Cornwall Hospital Truro Cornwall TR4 8AE 01872 253133;
15 January 2006
Email:
drdsje@hotmail.com
Citation: EBM Critical Appraisals. Scottish
Intensive Care Society EBM Group. 2006 & JICS 2006 Vol7(1). Elliott D.
Pearse et al. Early goal-directed therapy after major surgery reduces
complications and duration of hospital stay. A randomised, controlled trial.
Critical Care 2005, 9:R687-R693
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©SICS EBM 2006
Kill or Update By: January 2011
Reviewed & Edited by CC & BLT
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