Dataset Information

Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial.

ABSTRACT:

Importance

Corticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain.

Objective

To determine whether intraoperative administration of dexamethasone is more effective than placebo for reducing major complications and mortality during pediatric cardiac surgery.

Design, setting, and participants

The Intraoperative Dexamethasone in Pediatric Cardiac Surgery was an investigator-initiated, double-blind, multicenter randomized trial that involved 4 centers in China, Brazil, and Russia. A total of 394 infants younger than 12 months, undergoing cardiac surgery with cardiopulmonary bypass were enrolled from December 2015 to October 2018, with follow-up completed in November 2018.

Interventions

The dexamethasone group (n?=?194) received 1 mg/kg of dexamethasone; the control group (n?=?200) received an equivolume of 0.9% sodium chloride intravenously after anesthesia induction.

Main outcomes and measures

The primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery. There were 17 secondary end points, including the individual components of the primary end point, and duration of mechanical ventilation, inotropic index, intensive care unit stay, readmission to intensive care unit, and length of hospitalization.

Results

All of the 394 patients randomized (median age, 6 months; 47.2% boys) completed the trial. The primary end point occurred in 74 patients (38.1%) in the dexamethasone group vs 91 patients (45.5%) in the control group (absolute risk reduction, 7.4%; 95% CI, -0.8% to 15.3%; hazard ratio, 0.82; 95% CI, 0.60 to 1.10; P?=?.20). Of the 17 prespecified secondary end points, none showed a statistically significant difference between groups. Infections occurred in 4 patients (2.0%) in the dexamethasone group vs 3 patients (1.5%) in the control group.

Conclusions and relevance

Among infants younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative administration of dexamethasone, compared with placebo, did not significantly reduce major complications and mortality at 30 days. However, the study may have been underpowered to detect a clinically important difference.

Trial registration

ClinicalTrials.gov Identifier: NCT02615262.

SUBMITTER: Lomivorotov V

PROVIDER: S-EPMC7312411 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial.

Lomivorotov Vladimir V Kornilov Igor I Boboshko Vladimir V Shmyrev Vladimir V Bondarenko Ilya I Soynov Ilya I Voytov Alexey A Polyanskih Stanislav S Strunin Oleg O Bogachev-Prokophiev Alexander A Landoni Giovanni G Nigro Neto Caetano C Oliveira Nicolau Gretel G Saurith Izquierdo Leonardo L Nogueira Nascimento Vinícius V Wen Zhang Z Renjie Hu H Haibo Zhang Z Bazylev Vladlen V Evdokimov Mikhail M Sulejmanov Shahrijar S Chernogrivov Aleksei A Ponomarev Dmitry D

JAMA 20200601 24

<h4>Importance</h4>Corticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain.<h4>Objective</h4>To determine whether intraoperative administration of dexamethasone is more effective than placebo for reducing major complications and mortality during pediatric cardiac surgery.<h4>Design, setting, and participants</h4>The Intraoperative Dexamethasone in Pediatric Cardiac Surgery ...[more]

PMID: 32573670

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Project description:ObjectiveTo assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery.DesignPhase III, randomised, double blind, placebo controlled trial.Setting34 centres in France, December 2017 to March 2019.Participants1222 adults (>50 years) requiring major non-cardiac surgery with an expected duration of more than 90 minutes. The anticipated time frame for recruitment was 24 months.InterventionsParticipants were randomised to receive either dexamethasone (0.2 mg/kg immediately after the surgical procedure, and on day 1) or placebo. Randomisation was stratified on the two prespecified criteria of cancer and thoracic procedure.Main outcomes measuresThe primary outcome was a composite of postoperative complications or all cause mortality within 14 days after surgery, assessed in the modified intention-to-treat population (at least one treatment administered).ResultsOf the 1222 participants who underwent randomisation, 1184 (96.9%) were included in the modified intention-to-treat population. 14 days after surgery, 101 of 595 participants (17.0%) in the dexamethasone group and 117 of 589 (19.9%) in the placebo group had complications or died (adjusted odds ratio 0.81, 95% confidence interval 0.60 to 1.08; P=0.15). In the stratum of participants who underwent non-thoracic surgery (n=1038), the primary outcome occurred in 69 of 520 participants (13.3%) in the dexamethasone group and 93 of 518 (18%) in the placebo group (adjusted odds ratio 0.70, 0.50 to 0.99). Adverse events were reported in 288 of 613 participants (47.0%) in the dexamethasone group and 296 of 609 (48.6%) in the placebo group (P=0.46).ConclusionsDexamethasone was not found to significantly reduce the incidence of complications and death in patients 14 days after major non-cardiac surgery. The 95% confidence interval for the main result was, however, wide and suggests the possibility of important clinical effectiveness.Trial registrationClinicalTrials.gov NCT03218553.

Project description:BackgroundCompared with historic ventilation strategies, modern lung-protective ventilation includes lower tidal volumes (VT), lower driving pressures, and application of positive end-expiratory pressure (PEEP). The contributions of each component to an overall intraoperative protective ventilation strategy aimed at reducing postoperative pulmonary complications have neither been adequately resolved, nor comprehensively evaluated within an adult cardiac surgical population. The authors hypothesized that a bundled intraoperative protective ventilation strategy was independently associated with decreased odds of pulmonary complications after cardiac surgery.MethodsIn this observational cohort study, the authors reviewed nonemergent cardiac surgical procedures using cardiopulmonary bypass at a tertiary care academic medical center from 2006 to 2017. The authors tested associations between bundled or component intraoperative protective ventilation strategies (VT below 8 ml/kg ideal body weight, modified driving pressure [peak inspiratory pressure - PEEP] below 16 cm H2O, and PEEP greater than or equal to 5 cm H2O) and postoperative outcomes, adjusting for previously identified risk factors. The primary outcome was a composite pulmonary complication; secondary outcomes included individual pulmonary complications, postoperative mortality, as well as durations of mechanical ventilation, intensive care unit stay, and hospital stay.ResultsAmong 4,694 cases reviewed, 513 (10.9%) experienced pulmonary complications. After adjustment, an intraoperative lung-protective ventilation bundle was associated with decreased pulmonary complications (adjusted odds ratio, 0.56; 95% CI, 0.42-0.75). Via a sensitivity analysis, modified driving pressure below 16 cm H2O was independently associated with decreased pulmonary complications (adjusted odds ratio, 0.51; 95% CI, 0.39-0.66), but VT below 8 ml/kg and PEEP greater than or equal to 5 cm H2O were not.ConclusionsThe authors identified an intraoperative lung-protective ventilation bundle as independently associated with pulmonary complications after cardiac surgery. The findings offer insight into components of protective ventilation associated with adverse outcomes and may serve as targets for future prospective interventional studies investigating the impact of specific protective ventilation strategies on postoperative outcomes after cardiac surgery.

Project description:BackgroundPostoperative pulmonary complications (PPCs) have an impact on the recovery of adults after surgery. It is therefore important to establish whether preoperative respiratory rehabilitation can decrease the risk of PPCs and to identify adults who might benefit from respiratory rehabilitation.ObjectivesOur primary objective was to assess the effectiveness of preoperative inspiratory muscle training (IMT) on PPCs in adults undergoing cardiac or major abdominal surgery. We looked at all-cause mortality and adverse events.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2014, Issue 10), MEDLINE (1966 to October 2014), EMBASE (1980 to October 2014), CINAHL (1982 to October 2014), LILACS (1982 to October 2014), and ISI Web of Science (1985 to October 2014). We did not impose any language restrictions.Selection criteriaWe included randomized controlled trials that compared preoperative IMT and usual preoperative care for adults undergoing cardiac or major abdominal surgery.Data collection and analysisTwo or more review authors independently identified studies, assessed trial quality, and extracted data. We extracted the following information: study characteristics, participant characteristics, intervention details, and outcome measures. We contacted study authors for additional information in order to identify any unpublished data.Main resultsWe included 12 trials with 695 participants; five trials included participants awaiting elective cardiac surgery and seven trials included participants awaiting elective major abdominal surgery. All trials contained at least one domain judged to be at high or unclear risk of bias. Of greatest concern was the risk of bias associated with inadequate blinding, as it was impossible to blind participants due to the nature of the study designs. We could pool postoperative atelectasis in seven trials (443 participants) and postoperative pneumonia in 11 trials (675 participants) in a meta-analysis. Preoperative IMT was associated with a reduction of postoperative atelectasis and pneumonia, compared with usual care or non-exercise intervention (respectively; risk ratio (RR) 0.53, 95% confidence interval (CI) 0.34 to 0.82 and RR 0.45, 95% CI 0.26 to 0.77). We could pool all-cause mortality within postoperative period in seven trials (431 participants) in a meta-analysis. However, the effect of IMT on all-cause postoperative mortality is uncertain (RR 0.40, 95% CI 0.04 to 4.23). Eight trials reported the incidence of adverse events caused by IMT. All of these trials reported that there were no adverse events in both groups. We could pool the mean duration of hospital stay in six trials (424 participants) in a meta-analysis. Preoperative IMT was associated with reduced length of hospital stay (MD -1.33, 95% CI -2.53 to -0.13). According to the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group guidelines for evaluating the impact of healthcare interventions, the overall quality of studies for the incidence of pneumonia was moderate, whereas the overall quality of studies for the incidence of atelectasis, all-cause postoperative death, adverse events, and duration of hospital stay was low or very low.Authors' conclusionsWe found evidence that preoperative IMT was associated with a reduction of postoperative atelectasis, pneumonia, and duration of hospital stay in adults undergoing cardiac and major abdominal surgery. The potential for overestimation of treatment effect due to lack of adequate blinding, small-study effects, and publication bias needs to be considered when interpreting the present findings.

Project description:BackgroundSarcopenia is a surrogate marker for malnutrition and frailty, which has been linked to higher complication rates and prolonged length of stay (LOS) after surgery. The study aim was to assess the correlation between computed tomography (CT)-based sarcopenia and short-term clinical outcomes after oncologic colon surgery.MethodsThis retrospective study included consecutive patients operated between May 2014 and December 2019. Three radiological indices of sarcopenia were measured at the level of the third lumbar vertebra on preoperative CT scans: skeletal muscle area (SMA), skeletal muscle index (SMI) (both markers of muscle quantity), and skeletal muscle radiation attenuation (SMRA) (marker of muscle quality). Patients with major complications (grade ≥ 3b according to the Clavien classification) were compared with those without. Statistical correlation between sarcopenia indices, LOS, and comprehensive complication index (CCI) was tested with the Pearson correlation coefficient.ResultsA total of 325 patients were included. Mean age was 67 years [standard deviation (SD) 14.3], mean body mass index was 26.0 kg/m2 (SD 5.3), and 193 (59%) were male. Fifty patients (15.4%) had major complications, while 275 (84.6%) did not. Patients with major complications had more open surgery (52 vs. 21%, P < 0.01), intraoperative blood loss (257 vs. 102 mL, P = 0.035), and intraoperative complications (22 vs. 9%, P = 0.012). Patients with major complications had significantly increased CCI scores (53 vs. 6, P < 0.01), reoperations (74 vs. 0%, P < 0.01), and LOS (33 vs. 7, P < 0.01). SMA and SMI were comparable between both groups (126.0 vs. 125.2 cm2 , P = 0.974, and 43.4 vs. 44.3 cm2 /m2 , P = 0.636, respectively), while SMRA was significantly lower in patients with major complications (33.6 vs. 37.3 HU, P = 0.018). A lower SMRA was correlated with prolonged LOS (r = -0.207, P < 0.01) and higher CCI (r = -0.144, P < 0.01), while the other sarcopenia indices had no influence on surgical outcomes.ConclusionsMuscle quality (SMRA) as a specific sarcopenia marker was lower in patients with major complications and seems to prevail over muscle quantity (SMA and SMI) in the prediction of adverse outcomes after oncologic colon surgery.

Dataset Information

Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery: The DECISION Randomized Clinical Trial.

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