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Use of pulmonary artery catheter guided goal-directed therapy in high risk
surgical patients offers no clinical advantage or disadvantage in terms of
mortality.
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PAFC-guided goal-directed therapy in elderly ASA III
or IV patients undergoing elective or urgent major surgery offers no
advantage over conventional therapy but is not associated with increased
mortality. This study also demonstrates the feasibility of large randomised
trials of pulmonary artery catheters.
Level of Evidence: 1++ |
Citation/s:
Sandham J D, Hull R D, Brant RF et al. A Randomised , Controlled Trial of the
Use of Pulmonary-Artery Catheters in High Risk Surgical Patients. New Engl J Med
2003: 348(1); 5-14.
Lead author's name and fax: James Dean Sandham.
sandham@ucalgary.ca
Three-part
Clinical Question: Does goal-directed therapy guided by pulmonary artery
catheterisation in elderly ASA III or IV patients undergoing elective or urgent
major surgery improve outcomes compared with standard care.
Search Terms: Journal club
The Study:
Single-blinded concealed randomised controlled trial with intention-to-treat.
The Study Patients: All patients >60 yrs age, ASA III or IV and
undergoing major elective or urgent abdominal, thoracic, vascular or hip #
surgery were eligible. Of 3803 eligible patients, 1994 (52.4%) randomised. The
remainder either refused consent, were not referred or no ICU bed was available.
The patients were recruited from 1990 - 1999. The 2 randomised groups showed no
significant differences in baseline characteristics although the patients not
enrolled tended to be female, older, ASA III and had a lower incidence of MI and
angina.
Control group (N = 997; 997 analysed): The standard care group were
managed without the use of a PAFC or goals to direct therapy. Measurement of
central venous pressure was allowed. All patients were admitted to ICU
postoperatively.
Experimental group (N = 997; 997 analysed): The experimental group had
PAFC's sited preoperatively and an attempt was made to achieve the following
goals: DO2I 550-600 ml/min/m2, CI 3.5-4.5 l/min/m2,
MAP ³ 70mmHg, PCWP
³18 mmHg, HR 27%. Fluid loading,
inotropic therapy, vasodilators, vasopressors and blood transfusion were
suggested therapy. CI and DO2I were met in 18.6% and 21% pre-op and
79 and 62.9% respectively post-op.
The Evidence:
|
Outcome |
Time to
Outcome |
CER |
EER |
RRR |
ARR |
NNT |
|
Death |
Hospital |
0.077 |
0.078 |
-1% |
-0.001 |
-1000 |
|
95% Confidence
Intervals: |
-32% to 29% |
-0.024 to
0.022 |
NNT = 44 to
INF; NNH = 41 to INF |
|
Death
|
12 months |
0.155 |
0.163 |
-5% |
-0.008 |
-125 |
|
95% Confidence
Intervals: |
-26% to 16% |
-0.040 to
0.024 |
NNT = 41 to
INF; NNH = 25 to INF |
Comments:
The authors are very careful to point out that this is a study looking at a
specific therapeutic approach in a specific group of patients undergoing
specific procedures followed by a stay in ICU and is not generalisable to other
instances where PAFC's are used. In this sense it is as much a study of
preoptimisation as of the use of PAFC's (although only about 20% of patients in
the PAFC group attained DO2I and CI goals preoperatively).
More patients in the PAFC group received inotropes, vasodilators,
antihypertensives, packed cells & colloids.
Morbidity data were also evaluated. Length of hospital stay (10d), MI, CCF, SVT,
VT, sepsis, pneumonia, wound infection, hepatic and renal insufficiency
(pre-defined categories) were similar between the 2 groups. The only significant
difference between the 2 groups was in incidence of pulmonary embolism (0 vs. 8
in PAFC, p=0.004).
The use of PAFC's for these indications is rare in the UK outside specific
surgical areas (e.g. cardiac & hepatic surgery).
Appraised by: Murray Geddes,
Intensive Care Unit, Royal Infirmary of Edinburgh.; 18 February 2003
Email: mgeddes@btinternet.com
Kill or Update By: February 2008
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