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Early goal-directed therapy after major surgery reduces complications and duration of hospital stay.

 

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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Kill or Update By: January 2011

 

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