Goal-Directed Resuscitation for Patients with Early Septic Shock
2014 · paper · Clinical trials
A trial of 1,600 emergency department patients with early septic shock, randomly given early goal-directed therapy or usual care. Death at 90 days was nearly identical (18.6% vs 18.8%), so the therapy did not reduce mortality.
1 finding
Reference or label Table 2 footnote *: "Risk differences of less than 1.0 indicate better results in the EGDT group". The footnote is attached to the Risk Difference column, which is in percentage points with a null of 0.
- p. 7 Table 2, footnote * (attached to the 'Risk Difference (95% CI)' column)
Risk differences of less than 1.0 indicate better results in the EGDT group.
Judge's note: In the upright page 7 image, the asterisk is on 'Risk Difference (95% CI)*' and the column is labelled 'percentage points'. Values such as -0.3 and 10.5 are EGDT minus usual-care differences, so the threshold should be 0. A threshold of 1.0 applies only to the relative-risk column.
Second check: another model agreed
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8 minor (typos and the like; most checked by the judge only)
Reference or label Figure 2 legend: "Panel A shows Kaplan–Meier estimates of the probability of death at 90 days", but Panel A is titled 'Survival' and its y-axis is 'Probability of Survival'.
- p. 8 Figure 2 caption vs Panel A y-axis
Panel A shows Kaplan–Meier estimates of the probability of death at 90 days
- p. 8 Figure 2A y-axis
Probability of Survival
- p. 8 Figure 2 legend, panel A
Kaplan–Meier estimates of the probability of death at 90 days
Judge's note: On the page 8 image, Panel A's curves start at 1.00 and fall to about 0.81. The figure title also reads 'Probability of Survival...'. The legend names the complementary quantity, so it is a label mismatch; the data are unaffected.
Second check: another model agreed
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Wording Figure 2A lists 677 EGDT patients at risk at day 30, but Table 2 reports 117/792 EGDT deaths by day 28, which leaves at most 675 at risk.
- p. 8 Figure 2A, No. at Risk, EGDT row, day 30
677
- p. 7 Table 2, Death by day 28, EGDT
117/792 (14.8)
Only the authors can say what is right here.
Judge's note: Figure 2A (page 8) has the EGDT row 792, 677, 660, 646. Table 2 (page 7) gives death by day 28 for EGDT as 117/792, the same denominator as the KM cohort. The number at risk cannot exceed the survivors at day 28. The usual-care row is also off by one: 796 - 127 = 669, but 670 is printed (the Table 2 denominator there is 797). Only the authors can say which figure is right.
Second check: another model agreed
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Typo Results, Study Patients: "557 (69.8%) in the usual-case group" should read "usual-care group".
- p. 4 Results, Study Patients, 2nd paragraph
557 (69.8%) in the usual-case group
- p. 4 Results, Study Patients and Interventions
usual-case group
- p. 4 Study Patients, para 2
in the usual-case group. The criterion for an elevated lactate
- p. 4 Results
EDGT group
Judge's note: The page 4 image shows 'usual-case group' in the sentence on refractory hypotension. The arm is called 'usual care' everywhere else. The second occurrence (ICU admission) is C002, and the EDGT and 'absence or' typos named in some reviewer notes are C003 and C004.
Second check: none (judge only)
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Typo Interventions and Therapies: "614 (76.9%) in the usual-case group (P<0.001)" should read "usual-care group".
- p. 4 Results, Interventions and Therapies, first sentence
614 (76.9%) in the usual-case group (P<0.001)
- p. 4 Interventions and Therapies
614 (76.9%) in the usual- case group
- p. 4
usual-case group (P<0.001)
Judge's note: The page 4 image, right column, shows 'usual-' / 'case group' across a line break. This is a separate occurrence from C001.
Second check: none (judge only)
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Typo Study Patients: "2.8 hours (interquartile range, 2.1 to 3.9) in the EDGT group" should read "EGDT group".
- p. 4 Results, Study Patients, end of 2nd paragraph
EDGT group
- p. 4 Study Patients, last paragraph
EDGT group and 2.7 hours
Judge's note: The page 4 image shows 'EDGT group'. The abbreviation is EGDT everywhere else.
Second check: none (judge only)
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Typo Statistical Analysis: "presence or absence or refractory hypotension" should read "presence or absence of refractory hypotension".
- p. 4 Statistical Analysis, subgroup paragraph
presence or absence or re-
- p. 4 Statistical Analysis, subgroup analyses
presence or absence or re- fractory hypotension
Judge's note: The page 4 image, left column, shows 'presence or absence or re-fractory hypotension'. The parallel phrase in the same sentence reads 'presence or absence of invasive mechanical ventilation'.
Second check: none (judge only)
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Typo Figure 2B subgroup label "Hypofusion" should read "Hypoperfusion".
- p. 8 Figure 2B, subgroup label
Hypofusion
- p. 4 Methods, subgroup analyses
lactate level (<4.0 mmol
Judge's note: The page 8 image shows 'Hypofusion'. The subgroup counts (365 and 369 'Yes') match the elevated-lactate counts on page 4, so this is the lactate subgroup from the Methods and only the spelling is wrong.
Second check: none (judge only)
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Typo Reference 20: "Hebert PC, Wells G Blajchman MA, et al." is missing the comma after "Wells G".
- p. 10 Reference 20
Hebert PC, Wells G Blajchman MA
- p. 10 Reference 20
Hebert PC, Wells G Blajchman MA, et al.
Judge's note: The crop of page 10 shows the comma missing in print. Every other author list separates names with commas.
Second check: none (judge only)