Goal-directed therapy with bolus albumin 5% is not superior to bolus ringer acetate in maintaining systemic and mesenteric oxygen delivery in major upper abdominal surgery: A randomised controlled trial.

BACKGROUND: Goal-directed therapy (GDT) is increasingly used in abdominal surgery. Whether crystalloids can exert the same effect as colloid, and how this may affect perfusion, is still unclear. The effect of GDT on the systemic oxygen delivery index (sDO2I) and the mesenteric oxygen delivery index (mDO2I) can be quantified by measuring cardiac index and flow in the superior mesenteric artery, respectively. OBJECTIVE: The aim of this study was to test the hypothesis that intra-operative GDT with bolus human albumin 5% is superior to GDT with bolus ringer acetate in maintaining sDO2I and mDO2I in elective major upper gastrointestinal cancer surgery. DESIGN: Randomised controlled double blinded trial. SETTING: Odense University Hospital, Denmark, from May 2014 to June 2015. PATIENTS: A total of 89 adults scheduled for elective major upper gastrointestinal cancer surgery were randomised and data from 60 were analysed. EXCLUSION CRITERIA: contraindications for using the LiDCOplus system, known allergy to albumin, pre-operative renal failure, pancreatic cancer and pre-operative down staging using chemotherapy and/or radiation therapy, pregnancy. INTERVENTIONS: Patients were randomised to intra-operative GDT with either bolus human albumin or ringer acetate 250 ml, guided by pulse pressure variation and stroke volume. MAIN OUTCOME MEASURES: Changes in sDO2I and mDO2I. Secondary outcomes were changes in other haemodynamic variables, fluid balance, blood transfusions, fluid-related complications and length of stay (LOS) in ICU and hospital. RESULTS: Median [IQR] sDO2I was 522 [420 to 665] ml min m in the ringer acetate group and 490 [363 to 676] ml min m in the human albumin group, P = 0.36. Median [IQR] mDO2I was 12.1 [5.8 to 28.7] ml min m in the ringer acetate group and 17.0 [7.6 to 27.5] ml min m in the human albumin group, P = 0.17. Other haemodynamic comparisons did not differ significantly. More trial fluid was administered in the ringer acetate group. We found no significant difference in transfusions, complications or LOS. CONCLUSION: Bolus human albumin 5% was not superior to bolus ringer acetate in maintaining systemic or mesenteric oxygen delivery in elective major upper gastrointestinal cancer surgery, despite the administration of larger volumes of trial fluid in the ringer acetate group. No significant difference was seen in fluid-related complications or LOS. TRIAL REGISTRATION: https://eudract.ema.europa.eu/ Identifier: 2013-002217-36.

A randomised controlled trial of lidocaine infusion on post-operative opioid consumption in patients undergoing robotic colorectal surgery.

INTRODUCTION: Intravenous lidocaine has been shown to have analgesic effects leading to a reduced post-operative opiate need, but this effect is still debated in various surgical populations. We investigated whether this effect could be demonstrated in robot-assisted colorectal surgery. METHODS: A total of 60 adult patients undergoing robot-assisted colorectal surgery were randomly assigned to two groups in this prospective, double-blinded trial. The lidocaine group was treated with intravenous lidocaine. Treatment was initiated before induction of anaesthesia with a bolus of 1.5 mg/kg and immediately followed by infusion of 1.5 mg/kg/h continued until 2 h after end of surgery. The control group received placebo treatment with an equal volume and a dosing of 0.9% saline. The follow-up period was 72 h. RESULTS: No significant difference between groups in the median cumulated morphine consumption at 24 and 72 h was observed. Nor were there any differences in pain score, use of antiemetics, time until flatus and/or defecation or length of hospital stay. CONCLUSIONS: In this randomised, double-blinded, prospective study using intravenous lidocaine versus 0.9% saline in robot-assisted colorectal surgery, we found no significant difference in post-operative cumulated morphine consumption at 24 or at 72 h. FUNDING: The study received funding from DASAIMs Forskningsinitiativ (2016) and DASAIMs Smerteforskningspris (2016). TRIAL REGISTRATION: The trial is registered with EudraCT (2014-003466-25) and ClinicalTrials.gov (ID: NCT03044808).

Improving quality of care in peptic ulcer bleeding: nationwide cohort study of 13,498 consecutive patients in the Danish Clinical Register of Emergency Surgery.

OBJECTIVES: The treatment of peptic ulcer bleeding (PUB) is complex, and mortality remains high. We present results from a nationwide initiative to monitor and improve the quality of care (QOC) in PUB. METHODS: All Danish hospitals treating PUB patients between 2004 and 2011 prospectively registered demographic, clinical, and prognostic data. QOC was evaluated using eight process and outcome indicators, including time to initial endoscopy, hemostasis obtainment, proportion undergoing surgery, rebleeding risks, and 30-day mortality. RESULTS: A total of 13,498 PUB patients (median age 74 years) were included, of which one-quarter were in-hospital bleeders. Preadmission use of anticoagulants, multiple coexisting diseases, and the American Society of Anesthesiologists scores increased between 2004 and 2011. Considerable improvements were observed for most QOC indicators over time. Endoscopic treatment was successful with primary hemostasis achieved in more patients (94% in 2010-2011 vs. 89% in 2004-2006, relative risk (RR) 1.06 (95% confidence intervals 1.04-1.08)), endoscopy delay for hemodynamically unstable patients decreased during this period (43% vs. 34% had endoscopy within 6 h, RR 1.33 (1.10-1.61)), and fewer patients underwent open surgery (4% vs. 6%, RR 0.72 (0.59-0.87)). After controlling for time changes in prognostic factors, rebleeding rates improved (13% vs. 18%, adjusted RR 0.77 (0.66-0.91)). Crude 30-day mortality was unchanged (11% vs. 11%), whereas adjusted mortality decreased nonsignificantly over time (adjusted RR 0.89 (0.78-1.00)). CONCLUSIONS: QOC in PUB has improved substantially in Denmark, but the 30-day mortality remains high. Future initiatives to improve outcomes may include earlier endoscopy, having fully trained endoscopists on call, and increased focus on managing coexisting disease.