June 10, 2015Critical CareOpen Access

A randomized controlled trial on the effects of goal-directed therapy on the inflammatory response open abdominal aortic aneurysm repair

Q: What is the clinical evidence from this study?

Study design: RCT. Population: Abdominal aortic aneurysm (n=40). Intervention: Goal-directed therapy vs. Fluid therapy at the discretion of the attending anesthesiologist. Primary outcome: Hospital length of stay (p=0.73).

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Key result

Goal-directed therapy during open abdominal aortic aneurysm repair did not reduce hospital length of stay (median 8 vs 8 days, p=0.73) or inflammatory response, despite reducing total postoperative complications (12 vs 28, p=0.02).

Why the study?

Does goal-directed therapy targeting stroke volume variation reduce the inflammatory response and postoperative complications in patients undergoing elective open abdominal aortic aneurysm repair?

Population

40 adult patients undergoing elective open repair of abdominal aortic aneurysm. Exclusions: age >80 years…

Comparison

Goal-directed therapy targeting stroke volume… vs Standard fluid therapy administered at the…

Design

RCT, Randomized to either the intervention or control group by way of a sealed…

Follow-up

Up to 24 hours for biomarkers; hospital stay for clinical…

Authors

DFDuane J. FunkUniversity of Manitoba KHKent T. HayGlassUniversity of Toronto JKJoshua KoulackManitoba Health

Discussion

Member takes

Implication

GDT cuts complications in open AAA repair without changing inflammatory markers; confirms hemodynamic gains drive benefit and leaves mechanism otherwise open.

Study Design

Type

RCT (n=40)

Blinding

Single-blind

Randomization

Sealed envelope

Multicenter

Structured PICO

Does goal-directed therapy targeting stroke volume variation reduce the inflammatory response and postoperative complications in patients undergoing elective open abdominal aortic aneurysm repair?

Population

40 adults aged 18-80 years undergoing elective open repair of an abdominal aortic aneurysm were randomized to goal-directed therapy or standard fluid management to assess inflammatory response and clinical outcomes.

Intervention

Goal-directed therapy (GDT) targeting stroke volume variation (SVV) <13% using an arterial pulse contour cardiac output monitor (FloTrac/Vigeleo). Patients received a background crystalloid infusion of 3 cm³/kg ideal body weight of lactated Ringers. If SVV >13%, 250 ml 130/0.4 hydroxyethyl starch (HES) solution was administered, repeated until SVV <13% (up to max 55 cm³/kg).

Comparator

Standard fluid therapy administered at the discretion of the attending anesthesiologist (typically based on static preload variables like CVP or low MAP). Anesthesiologists were blinded to cardiac index and SVV data via an opaque index card over the monitor. Colloid administration was exclusively 130/0.4 HES.

Outcome

Levels of inflammatory cytokines (IL-10, IL-6, PTX3, CRP, ST-2, MCP-1, IL-1Ra, sTNFR-II) measured preoperatively and at immediate, 6-hour, and 24-hour postoperative time points, and hospital length of stay (which the study was powered for).surrogate

Main Result

Absolute Event Rate: 8% vs 8%

p-value: p=0.73

Goal-directed therapy during open abdominal aortic aneurysm repair reduces postoperative complications and improves hemodynamics, but does not alter the systemic inflammatory response or length of hospital stay.

Limitations

Small sample size
Inability to measure cardiac index in the postoperative period
Cytokine levels only measured up to 24 hours
Did not measure lactate in the postoperative period
Utilizing a SVV target of 13% is in a 'grey zone' of fluid responsiveness
Study was powered for length of stay rather than inflammatory biomarker levels
Length of stay may be confounded by factors unrelated to hemodynamics, such as delays for home-care services

Cite This Study

Funk et al. (2015) conducted an RCT in Abdominal aortic aneurysm (n=40). Goal-directed therapy vs. Fluid therapy at the discretion of the attending anesthesiologist was evaluated on Hospital length of stay (p=0.73). Goal-directed therapy during open abdominal aortic aneurysm repair did not reduce hospital length of stay (median 8 vs 8 days, p=0.73) or inflammatory response, despite reducing total postoperative complications (12 vs 28, p=0.02).

synapsesocial.com/papers/6a6d2b9b35aa2c282cdfd01d https://doi.org/10.1186/s13054-015-0974-x

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Implication

GDT cuts complications in open AAA repair without changing inflammatory markers; confirms hemodynamic gains drive benefit and leaves mechanism otherwise open.

A randomized controlled trial on the effects of goal-directed therapy on the inflammatory response open abdominal aortic aneurysm repair

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

A randomized controlled trial on the effects of goal-directed therapy on the inflammatory response open abdominal aortic aneurysm repair

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

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