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A randomized controlled trial of levosimendan to reduce mortality in high-risk cardiac surgery patients (CHEETAH): Rationale and design

Zangrillo A, Alvaro G, Pisano A, Guarracino F, Lobreglio R, Bradic N, et al.

Am Heart J, 2016 Jul;177:66-73.
PMID: 27297851 DOI: 10.1016/j.ahj.2016.03.021

OBJECTIVE: Patients undergoing cardiac surgery are at risk of perioperative low cardiac output syndrome due to postoperative myocardial dysfunction. Myocardial dysfunction in patients undergoing cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with 3 beneficial cardiovascular effects (inotropic, vasodilatory, and anti-inflammatory), which appears effective in improving clinically relevant outcomes.
DESIGN: Double-blind, placebo-controlled, multicenter randomized trial.
SETTING: Tertiary care hospitals.
INTERVENTIONS: Cardiac surgery patients (n = 1,000) with postoperative myocardial dysfunction (defined as patients with intraaortic balloon pump and/or high-dose standard inotropic support) will be randomized to receive a continuous infusion of either levosimendan (0.05-0.2 μg/[kg min]) or placebo for 24-48 hours.
MEASUREMENTS AND MAIN RESULTS: The primary end point will be 30-day mortality. Secondary end points will be mortality at 1 year, time on mechanical ventilation, acute kidney injury, decision to stop the study drug due to adverse events or to start open-label levosimendan, and length of intensive care unit and hospital stay. We will test the hypothesis that levosimendan reduces 30-day mortality in cardiac surgery patients with postoperative myocardial dysfunction.
CONCLUSIONS: This trial is planned to determine whether levosimendan could improve survival in patients with postoperative low cardiac output syndrome. The results of this double-blind, placebo-controlled randomized trial may provide important insights into the management of low cardiac output in cardiac surgery.

Matched MeSH terms: Infusions, Intravenous
Continuous infusion vs. bolus dosing: implications for beta-lactam antibiotics

Mohd Hafiz AA, Staatz CE, Kirkpatrick CM, Lipman J, Roberts JA

Minerva Anestesiol, 2012 Jan;78(1):94-104.
PMID: 21730935

Beta-lactam antibiotics display time-dependant pharmacodynamics whereby constant antibiotic concentrations rather than high peak concentrations are most likely to result in effective treatment of infections caused by susceptible bacteria. Continuous administration has been suggested as an alternative strategy, to conventional intermittent dosing, to optimise beta-lactam pharmacokinetic/pharmacodynamic (PK/PD) properties. With the availability of emerging data, we elected to systematically investigate the published literature describing the comparative PK/PD and clinical outcomes of beta-lactam antibiotics administered by continuous or intermittent infusion. We found that the studies have been performed in various patient populations including critically ill, cancer and cystic fibrosis patients. Available in vitro PK/PD data conclusively support the administration of beta-lactams via continuous infusion for maximizing bacterial killing from consistent attainment of pharmacodynamic end-points. In addition, clinical outcome data supports equivalence, even with the use of a lower dose by continuous infusion. However, the present clinical data is limited with small sample sizes common with insufficient power to detect advantages in favour of either dosing strategy. With abundant positive pre-clinical data as well as document in vivo PK/PD advantages, large multi-centre trials are needed to describe whether continuous administration of beta-lactams is truly more effective than intermittent dosing.

Matched MeSH terms: Infusions, Intravenous
Efficacy and safety of dexmedetomidine versus morphine in post-operative cardiac surgery patients

Abd Aziz N, Chue MC, Yong CY, Hassan Y, Awaisu A, Hassan J, et al.

Int J Clin Pharm, 2011 Apr;33(2):150-4.
PMID: 21744187 DOI: 10.1007/s11096-011-9480-7

OBJECTIVE: To compare the efficacy of dexmedetomidine versus morphine as a sedative/analgesic among post-operative cardiac surgery patients.
METHOD: A randomized controlled open-label study was performed at the cardiothoracic intensive care unit of Penang Hospital, Malaysia. A total of 28 patients who underwent cardiac surgeries were randomly assigned to receive either dexmedetomidine or morphine. Both groups were similar in terms of preoperative baseline characteristics. Efficacy measures included sedation scores and pain intensity and requirements for additional sedative/analgesic. Mean heart rate and arterial blood pressure were used as safety measures. Other measures were additional inotropes, extubation time and other concurrent medications.
RESULTS: The mean dose of dexmedetomidine infused was 0.12 [SD 0.03] μg kg⁻¹ h⁻¹, while that of morphine was 13.2 [SD 5.84] μg kg⁻¹ h⁻¹. Dexmedetomidine group showed more benefits in sedation and pain levels, additional sedative/analgesic requirements, and extubation time. No significant differences between the two groups for the outcome measures, except heart rate, which was significantly lower in the dexmedetomidine group.
CONCLUSION: This preliminary study suggests that dexmedetomidine was at least comparable to morphine in terms of efficacy and safety among cardiac surgery patients. Further studies with larger samples are recommended in order to determine the significant effects of the outcome measures.

Matched MeSH terms: Infusions, Intravenous
Hypersensitivity reactions to oxaliplatin in two asian patients

Ng CV

Ann Pharmacother, 2005 Jun;39(6):1114-8.
PMID: 15886290

To report 2 cases of hypersensitivity reactions associated with oxaliplatin treatment in Asian patients.

Matched MeSH terms: Infusions, Intravenous
Fulltext A metabolomic analysis of thiol response for standard and modified N-acetyl cysteine treatment regimens in patients with acetaminophen overdose

Dear JW, Ng ML, Bateman DN, Leroy Sivappiragasam P, Choi H, Khoo BBJ, et al.

Clin Transl Sci, 2021 Jul;14(4):1476-1489.
PMID: 33742775 DOI: 10.1111/cts.13009

N-acetylcysteine (NAC) is an antidote to prevent acetaminophen (paracetamol-APAP)-induced acute liver injury (ALI). The 3-bag licensed 20.25 h standard regimen, and a 12 h modified regimen, are used to treat APAP overdose. This study evaluated the redox thiol response and APAP metabolites, in patients with a single APAP overdose treated with either the 20.25 h standard or 12 h modified regimen. We used liquid chromatography tandem mass spectrometry to quantify clinically important oxidative stress biomarkers and APAP metabolites in plasma samples from 45 patients who participated in a randomized controlled trial (SNAP trial). We investigated the time course response of plasma metabolites at predose, 12 h, and 20.25 h post-start of NAC infusion. The results showed that the 12 h modified regimen resulted in a significant elevation of plasma NAC and cysteine concentrations at 12 h post-infusion. We found no significant alteration in the metabolism of APAP, mitochondrial, amino acids, and other thiol biomarkers with the two regimens. We examined APAP and purine metabolism in overdose patients who developed ALI. We showed the major APAP-metabolites and xanthine were significantly higher in patients with ALI. These biomarkers correlated well with alanine aminotransferase activity at admission. Receiver operating characteristic analysis showed that at admission, plasma APAP-metabolites and xanthine concentrations were predictive for ALI. In conclusion, a significantly higher redox thiol response with the modified NAC regimen at 12 h postdose suggests this regimen may produce greater antioxidant efficacy. At baseline, plasma APAP and purine metabolites may be useful biomarkers for early prediction of APAP-induced ALI.

Matched MeSH terms: Infusions, Intravenous
Fulltext Shewanella algae Peritonitis in Patients on Peritoneal Dialysis

Shanmuganathan M, Goh BL, Lim C, NorFadhlina Z, Fairol I

Perit Dial Int, 2016 9 24;36(5):574-5.
PMID: 27659933 DOI: 10.3747/pdi.2015.00287

Patients with peritonitis present with abdominal pain, diarrhea, fever, and turbid peritoneal dialysis (PD) fluid. Shewanella algae peritonitis has not yet been reported in PD patients in the literature. We present the first 2 cases of Shewanella algae peritonitis in PD patients. Mupirocin cream is applied on the exit site as prophylactic antibiotic therapy.

Matched MeSH terms: Infusions, Intravenous
The contribution of adrenoceptor subtype(s) in the renal vasculature of diabetic spontaneously hypertensive rats

Armenia A, Munavvar AS, Abdullah NA, Helmi A, Johns EJ

Br J Pharmacol, 2004 Jun;142(4):719-26.
PMID: 15172958

1. Diabetes and hypertension are both associated with an increased risk of renal disease and are associated with neuropathies, which can cause defective autonomic control of major organs including the kidney. This study aimed to examine the alpha(1)-adrenoceptor subtype(s) involved in mediating adrenergically induced renal vasoconstriction in a rat model of diabetes and hypertension. 2. Male spontaneously hypertensive rats (SHR), 220-280 g, were anaesthetized with sodium pentobarbitone 7-day poststreptozotocin (55 mg x kg(-1) i.p.) treatment. The reductions in renal blood flow (RBF) induced by increasing frequencies of electrical renal nerve stimulation (RNS), close intrarenal bolus doses of noradrenaline (NA), phenylephrine (PE) or methoxamine were determined before and after administration of nitrendipine (Nit), 5-methylurapidil (5-MeU), chloroethylclonidine (CEC) and BMY 7378. 3. In the nondiabetic SHR group, mean arterial pressure (MAP) was 146+/-6 mmHg, RBF was 28.0+/-1.4 ml x min(-1) x kg(-1) and blood glucose was 112.3+/-4.7 mg x dl(-1), and in the diabetic SHR Group, MAP was 144+/-3 mmHg, RBF 26.9+/-1.3 ml(-1) min x kg(-1) and blood glucose 316.2+/-10.5 mg x dl(-1). Nit, 5-MeU and BMY 7378 blunted all the adrenergically induced renal vasoconstrictor responses in SHR and diabetic SHR by 25-35% (all P<0.05), but in diabetic rats the responses induced by RNS and NA treated with 5-MeU were not changed. By contrast, during the administration of CEC, vasoconstrictor responses to all agonists were enhanced by 20-25% (all P<0.05) in both the SHR and diabetic SHR. 4. These findings suggest that alpha(1A) and alpha(1D)-adrenoceptor subtypes contribute in mediating the adrenergically induced constriction of the renal vasculature in both the SHR and diabetic SHR. There was also an indication of a greater contribution of presynaptic adrenoceptors, that is, alpha(1B)-, and/or alpha(2)-subtypes.

Matched MeSH terms: Infusions, Intravenous