Intensive alveolar recruitment after cardiac surgery: a randomized controlled clinical trial
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ABSTRACT:
SUBMITTER: Leme A
PROVIDER: S-EPMC4069607 | biostudies-literature | 2014 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundDexmedetomidine is a sedative agent that may have the potential to reduce the risk of post-intensive care syndrome (PICS). This study aimed to establish whether prophylactic nocturnal dexmedetomidine safely reduces postoperative PICS incidence and to develop an easy-to-use model for predicting the risk of PICS following cardiac surgery.MethodsThis was a single-center, double-blind, randomized, prospective, placebo-controlled trial. Patients undergoing cardiac surgery were randomly assigned (1:1) to dexmedetomidine or placebo (normal saline) groups between January 2019 and July 2020. Dexmedetomidine or a similar volume of saline was administered, with an infusion rate up to 1.2 μg/kg/h until the RASS remained between - 1 and 0. The primary study endpoint was PICS incidence at 6 months follow-up, as defined by cognitive, physical, or psychological impairments.ResultsWe assessed 703 individuals for eligibility, of whom 508 were enrolled. Of these, there were 251 in the dexmedetomidine group and 257 in the placebo group that received the trial agent, forming a modified intention-to-treat population. PICS incidence at 6-month follow-up was significantly decreased in the dexmedetomidine group (54/251, 21.5%) relative to the placebo group (80/257, 31.1%) (odds ratio [OR] 0.793, 95% CI 0.665-0.945; p = 0.014). Psychological impairment was significantly reduced in the dexmedetomidine group relative to the placebo group (18.7% vs. 26.8%, OR 0.806, CI 0.672-0.967, p = 0.029). However, dexmedetomidine treatment was associated with a higher rate of hypotension. A nomogram revealed that age, education, a medical history of diabetes and smoking, dexmedetomidine treatment, postoperative atrial fibrillation, and sequential organ failure assessment scores at 8 h post-surgery were independent predictors of PICS.ConclusionsProphylactic nocturnal dexmedetomidine administration significantly reduced PICS incidence by a marked reduction in psychological impairment within a 6-month follow-up period.Trial registrationChiCTR, ChiCTR1800014314 . Registered 5 January 2018, http://www.chictr.org.cn/index.aspx.
| S-EPMC8647374 | biostudies-literature
Project description:BackgroundIn patients who underwent cardiac surgery, first-time postoperative atrial fibrillation (POAF) is associated with increased incidence of hospital-acquired complications and mortality. Systemic inflammation is one of confirmed triggers of its development. The anti-inflammatory properties of colchicine can be effective for the POAF prevention. However, the results of several studies were questionable and required further investigation. Hence, we aimed to evaluate the effectiveness of low-dose short-term colchicine administration for POAF prevention in patients after the open-heart surgery. This double-blind randomized placebo-controlled trial included 267 patients, but 27 of them dropped out in the course of the study. Study subjects received the test drug on the day before the surgery and on postoperative days 2, 3, 4 and 5. The rhythm control was conducted immediately after the operation and until the discharge from the hospital. The final analysis included 240 study subjects: 113 in the colchicine group and 127 in the placebo group. POAF was observed in 21 (18.6%) patients of the colchicine group vs. 39 (30.7%) control patients (OR 0.515; 95% Cl 0.281-0.943; p = 0.029). We observed no statistically significant differences between the patient groups in the secondary endpoints of the study (hospital mortality, respiratory failure, stroke, bleeding, etc.). For other parameters characterizing the severity of inflammation (pericardial effusion, pleural effusion, WBC count, neutrophil count), there were statistically significant differences between the groups in the early postoperative period (days 3 and 5). Also, statistically significant differences between the groups in the frequency of adverse events were revealed: the incidence of diarrhea in the colchicine group was 25.7% vs. 11.8% in the placebo group (OR 2.578; 95% Cl 1.300-5.111; p = 0.005); for abdominal pain, incidence values were 7% vs. 1.6%, correspondingly (OR 4.762; 95% Cl 1.010-22.91; p = 0.028). Thus, there were statistically significant differences between groups in the primary endpoint, thereby confirming the effectiveness of short-term colchicine use for the POAF prevention after coronary artery bypass grafting and/or aortic valve replacement. Also, we detected statistically significant differences between groups in the frequency of side effects to colchicine: diarrhea and abdominal pain were more common in the colchicine group. This clinical trial is registered with ClinicalTrials database under a unique identifier: NCT04224545.
| S-EPMC9604685 | biostudies-literature
Project description:BackgroundThe Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy).ObjectiveTo describe the data management process and statistical analysis plan.MethodsThe statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes.ConclusionAccording to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results.Trial registrationClinicalTrials.gov number, NCT01374022.
| S-EPMC5496748 | biostudies-literature
Project description:BackgroundAlthough the intraoperative alveolar recruitment maneuver (RM) efficiently treats atelectasis, the effect of FIO2 on atelectasis during RM is uncertain. We hypothesized that a high FIO2 (1.0) during RM would lead to a higher degree of postoperative atelectasis without benefiting oxygenation when compared to low FIO2 (0.4).MethodsIn this randomized controlled trial, patients undergoing elective laparoscopic surgery in the Trendelenburg position were allocated to low- (FIO2 0.4, n = 44) and high-FIO2 (FIO2 1.0, n = 46) groups. RM was performed 1-min post tracheal intubation and post changes in supine and Trendelenburg positions during surgery. We set the intraoperative FIO2 at 0.4 for both groups and calculated the modified lung ultrasound score (LUSS) to assess lung aeration after anesthesia induction and at surgery completion. The primary outcome was modified LUSS at the end of the surgery. The secondary outcomes were the intra- and postoperative PaO2 to FIO2 ratio and postoperative pulmonary complications.ResultsThe modified LUSS before capnoperitoneum and RM (P = 0.747) were similar in both groups. However, the postoperative modified LUSS was significantly lower in the low FIO2 group (median difference 5.0, 95% CI 3.0-7.0, P < 0.001). Postoperatively, substantial atelectasis was more common in the high-FIO2 group (relative risk 1.77, 95% CI 1.27-2.47, P < 0.001). Intra- and postoperative PaO2 to FIO2 were similar with no postoperative pulmonary complications. Atelectasis occurred more frequently when RM was performed with high than with low FIO2; oxygenation was not benefitted by a high-FIO2. CONCLUSIONS: In patients undergoing laparoscopic surgery in the Trendelenburg position, absorption atelectasis occurred more frequently with high rather than low FIO2. No oxygenation benefit was observed in the high-FIO2 group.Trial registrationClinicalTrials.gov, NCT03943433 . Registered 7 May 2019.
| S-EPMC7368786 | biostudies-literature
Project description:AimTo compare the effectiveness of two-ridge preservation treatments.Materials and methodsForty subjects with extraction sockets exhibiting substantial buccal dehiscences were enrolled and randomized across 10 standardized centres. Treatments were demineralized allograft plus reconstituted and cross-linked collagen membrane (DFDBA + RECXC) or deproteinized bovine bone mineral with collagen plus native, bilayer collagen membrane (DBBMC + NBCM). Socket dimensions were recorded at baseline and 6 months. Wound closure and soft tissue inflammation were followed post-operatively, and biopsies were retrieved for histomorphometric analysis at 6 months.ResultsPrimary endpoint: at 6 months, extraction socket horizontal measures were significantly greater for DBBMC + NBCM (average 1.76 mm greater, p = 0.0256). Secondary and Exploratory endpoints: (1) lingual and buccal vertical bone changes were not significantly different between the two treatment modalities, (2) histomorphometric % new bone and % new bone + graft were not significantly different, but significantly more graft remnants remained for DBBMC; (3) at 1 month, incision line gaps were significantly greater and more incision lines remained open for DFDBA + RECXC; (4) higher inflammation at 1 week tended to correlate with lower ridge preservation results; and (5) deeper socket morphologies with thinner bony walls correlated with better ridge preservation. Thirty-seven of 40 sites had sufficient ridge dimension for implant placement at 6 months; the remainder were DFDBA + RECXC sites.ConclusionDBBMC + NBCM provided better soft tissue healing and ridge preservation for implant placement. Deeper extraction sockets with higher and more intact bony walls responded more favourably to ridge preservation therapy.
| S-EPMC5132058 | biostudies-literature
Project description:Functional electrical stimulation (FES) has shown benefits in patients with chronic heart failure. Therefore, it is possible that FES can benefit patients similarly after cardiac surgery.This randomized placebo-controlled trial aimed to evaluate the effects of FES on lower limb functional capacity, strength, endurance, and muscle mass after discharge from cardiac surgery.Twenty patients were allocated (1:1) to the group receiving FES to the quadriceps (FESG) or FES placebo (FESPG). FES was applied at a frequency of 15Hz, with 0.5ms pulse width, 5s contraction time, and 10s resting time, twice a week for 40min over a period of eight weeks. Functional capacity was assessed using the six-minute walk test (6MWT), lower limb muscle strength using the one repetition maximum test (1RM), endurance using the sit-and-stand test (SST), and muscle using the perimeter of the thighs.Both groups increased the distance covered in the 6MWT (FESG: 49.6m, 95% CI 15.9-83.3; FESPG: 41.5m, 95% CI 7.8-75.2), but without a difference between groups. There were significant between-group differences for quadriceps muscle strength (7.2kg, 95% CI 0.2-14.2) and muscle endurance (2.2 repetitions, 95% CI 1.0-3.4) in favor of the FESG.FES improves lower limb muscle strength and endurance in patients after cardiac surgery. Larger trials are needed to confirm our findings.
| S-EPMC5537479 | biostudies-other
Project description:BackgroundChildren undergoing cardiac surgery are at risk for acute kidney injury (AKI) and cardiac dysfunction. Opportunity exists in protecting end organ function with remote ischemic preconditioning. We hypothesize this intervention lessens kidney and myocardial injury.MethodsWe conducted a randomized, double blind, placebo controlled trial of remote ischemic preconditioning in children undergoing cardiac surgery. Pre-specified end points are change in creatinine, estimated glomerular filtration rate, development of AKI, B-type natriuretic peptide and troponin I at 6, 12, 24, 48, 72 h post separation from bypass.ResultsThere were 45 in the treatment and 39 patients in the control group, median age of 3.5 and 3.8 years, respectively. There were no differences between groups in creatinine, cystatin C, eGFR at each time point. There was a trend for a larger rate of decrease, especially for cystatin C (p = 0.042) in the treatment group but the magnitude was small. AKI was observed in 21 (54%) of control and 16 (36%) of treatment group (p = 0.094). Adjusting for baseline creatinine, the odds ratio for AKI in treatment versus control was 0.31 (p = 0.037); adjusting for clinical characteristics, the odds ratio was 0.34 (p = 0.056). There were no differences in natriuretic peptide or troponin levels between groups. All secondary end points of clinical outcomes were not different.ConclusionsThere is suggestion of RIPC delivering some kidney protection in an at-risk pediatric population. Larger, higher risk population studies will be required to determine its efficacy. Trial registration and date: Clinicaltrials.gov NCT01260259; 2021.
| S-EPMC10765905 | biostudies-literature
Project description:BackgroundBlood-based cardioplegia is the standard myocardial protection strategy in pediatric cardiac surgery. Custadiol (histidine-tryptophan-ketoglutarate), an alternative, may have some advantages but is potentially less effective at myocardial protection. This study aimed to test whether custadiol is not inferior to blood-based cardioplegia in pediatric cardiac surgery.MethodsThe study was designed as a randomized controlled trial with a blinded outcome assessment. All pediatric patients undergoing cardiac surgery with cardiopulmonary bypass and cardioplegia, including neonates, were eligible. Emergency surgery was excluded. The primary outcome was a composite of death within 30 days, an ICU stay longer than 5 days, or arrhythmia requiring intervention. Secondary endpoints included total hospital stay, inotropic score, cardiac troponin levels, ventricular function, and extended survival postdischarge. The sample size was determined a priori for a noninferiority design with an expected primary outcome of 40% and a clinical significance difference of 20%.ResultsBetween January 2018 and January 2021, 226 patients, divided into the Custodiol cardioplegia (CC) group (n = 107) and the blood cardioplegia (BC) group (n = 119), completed the study protocol. There was no difference in the composite endpoint between the CC and BC groups, 65 (60.75%) vs. 71 (59.66%), respectively (P = 0.87). The total length of stay in the hospital was 14 (Q2-Q3: 10-19) days in the CC group vs. 13 (10-21) days in the BC group (P = 0.85). The inotropic score was not significantly different between the CC and BC groups, 5 (2.6-7.45) vs. 5 (2.6-7.5), respectively (P = 0.82). The cardiac troponin level and ventricular function did not differ significantly between the two groups (P = 0.34 and P = 0.85, respectively). The median duration of follow-up was 32.75 (Q2-Q3: 18.73-41.53) months, and there was no difference in survival between the two groups (log-rank P = 0.55).ConclusionsCustodial cardioplegia is not inferior to blood cardioplegia for myocardial protection in pediatric patients. Trial registration The trial was registered in Clinicaltrials.gov, and the ClinicalTrials.gov Identifier number is NCT03082716 Date: 17/03/2017.
| S-EPMC10552411 | biostudies-literature
Project description:BackgroundOne potential strategy to increasing physical activity after surgery is to utilize an ambulation orderly (AO), a dedicated employee whose assures frequent patient walking. However, the impact of an AO on physical and functional recovery from surgery is unknown.MethodsWe randomized post-operative cardiac surgical patients to receive either the AO or usual care. We measured average daily step count, changes in 6-minute walk test (6MWT) distance, and changes in functional independence (Barthel Index.) Our primary goal was to test protocols, measure variability in activity, and establish effect sizes.ResultsThirty-six patients were randomized (18 per group, 45% bypass surgery). Overall, patients exhibited significant recovery of physical function from baseline to discharge in the 6MWT (from 83 to 172 meters, p < 0.001) and showed improvement in independent function (Barthel Index, 67 to 87, p <0.001). Moreover, each additional barrier to ambulation (supplemental oxygen, intravenous poles/fluid, walkers, urinary catheters, and chest tubes) reduced average daily step count by 330 steps/barrier, p = 0.04. However, the AO intervention resulted in only a small difference in average daily step counts (2718 vs. 2541 steps/day, Cohen's d = 0.16, 608 patients needed for larger trial), which we attributed to several trial factors that likely weakened the AO intervention.ConclusionsIn this pilot study, we observed significant in-hospital physical and functional recovery from surgery, but the addition of an AO made only marginal differences in daily step counts. Future studies should consider stepped-wedge or cluster trial designs to increase intervention effectiveness.Clinical trials registrationClinicaltrials.gov unique identifier: NCT02375282.
| S-EPMC6345535 | biostudies-literature
Project description:ObjectivesTo investigate if sevoflurane based anesthesia is superior to propofol in preventing lung inflammation and preventing postoperative pulmonary complications.DesignRandomized controlled trial.SettingSingle tertiary care university hospital.ParticipantsForty adults undergoing cardiac surgery with cardiopulmonary bypass.InterventionsPatients were randomized in a 1:1 ratio to anesthetic maintenance with sevoflurane or propofol.Measurements and main resultsBlood and bronchoalveolar lavage fluid was sampled before and after bypass to measure pulmonary inflammation using a biomarker panel. The change in bronchoalveolar lavage concentration of tumor necrosis factor alpha (TNFα) was the primary outcome. Secondary outcomes included lung inflammation defined as changes in other biomarkers and postoperative pulmonary complications. There were no significant differences between groups in the change in bronchoalveolar lavage TNFα concentration (median [IQR] change, 17.24 [1.11-536.77] v 101.51 [1.47-402.84] pg/mL, sevoflurane v propofol, p = 0.31). There was a significantly lower postbypass concentration of plasma interleukin 8 (median [IQR], 53.92 [34.5-55.91] v 66.92 [53.03-94.44] pg/mL, p = 0.04) and a significantly smaller postbypass increase in the plasma receptor for advanced glycosylation end products (median [IQR], 174.59 [73.59-446.06] v 548.22 [193.15-852.39] pg/mL, p = 0.03) in the sevoflurane group compared with propofol. The incidence of postoperative pulmonary complications was 100% in both groups, with high rates of pleural effusion (17/18 [94.44%] v 19/22 [86.36%], p = 0.39) and hypoxemia (16/18 [88.88%] v 22/22 [100%], p = 0.11).ConclusionsSevoflurane anesthesia during cardiac surgery did not consistently prevent lung inflammation or prevent postoperative pulmonary complications compared to propofol. There were significantly lower levels of 2 plasma biomarkers specific for lung injury and inflammation in the sevoflurane group.
| S-EPMC9728032 | biostudies-literature