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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

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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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Project description:BackgroundMismanagement of remifentanil leads to severe side effects such as opioid-induced tolerance and hyperalgesia. Recently studies revealed an alternative withdrawal method to limit these side effects. A gradual withdrawal of remifentanil seems to be associated with less pain. The hypothesis of this double-blinded, randomized controlled trial was that a gradual withdrawal of remifentanil would be associated with less immediate post-operative pain compared to after an abrupt discontinuation of remifentanil in patients who underwent thyroid surgery.MethodsThis double-blinded, randomized controlled trial was conducted in a tertiary level hospital in Brussels (Belgium) from April until August 2017. 34 patients undergoing thyroid surgery were randomized and 29 patients completed the study. After randomization, patients undergoing thyroid surgery were allocated to two groups: one with an abrupt discontinuation of remifentanil after surgery and one with a gradual withdrawal of remifentanil after surgery. The primary outcome was the initial post-operative demand of analgesic medication.ResultsGradual withdrawal of remifentanil was associated with a delayed initial post-operative demand of analgesic medication (P = 0.006). The first morphine bolus was given after 76.3 +/- 89.0 min in the group with a gradual withdrawal of remifentanil versus after 9.0 +/- 13.5 min in the group with an abrupt discontinuation of remifentanil. However, overall morphine consumption, numeric rating scale scores, Ramsay Sedation Scale scores, and quality of recovery scores (QoR-40) were similar in both groups (P > 0.05).ConclusionThough overall morphine consumption, numeric rating scale scores, Ramsay Sedation Scale scores, and quality of recovery scores (QoR-40) are not altered, a gradual withdrawal of remifentanil after thyroid surgery is safe and associated with a delayed initial post-operative demand of analgesic drugs. The withdrawal process does, however, require vigilance and training.Trial registrationClinicaltrials.gov NCT03110653 (PI: Luc Barvais; date of registration: 03/31/2017).

Dataset Information

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

Publications

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

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