Dataset Information

Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial.

ABSTRACT:

Background

Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a "real-world" trial in cardiac surgery.

Objective

We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient.

Design

A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy.

Setting

A large tertiary academic center in London Ontario between September 2009 and February 2011.

Participants

Patients undergoing planned, isolated coronary revascularization.

Measurements

Serum creatinine and patient weight were measured daily postoperatively.

Methods

Patients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization.

Results

The study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, "risk" occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9; P = 1.00), whereas "injury" occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups.

Limitations

The study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes.

Conclusions

This pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.

SUBMITTER: Nagpal AD

PROVIDER: S-EPMC7388134 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial.

Nagpal A Dave AD Cowan Andrea A Li Linna L Nusca Graeme G Guo Linrui L Novick Richard J RJ Harle Chris C CC House Andrew A AA Fox Stephanie S Jones Philip M PM

Canadian journal of kidney health and disease 20200728

<h4>Background</h4>Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a "real-world" trial in cardiac surgery.<h4>Objective</h4>We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient.<h4>Design</h4>A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strate ...[more]

PMID: 32782813

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Dataset Information

Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial.

Background

Objective

Design

Setting

Participants

Measurements

Methods

Results

Limitations

Conclusions

Publications

Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial.

Similar Datasets

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