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The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery - AIR: study protocol for a randomised controlled trial.

ABSTRACT: Administration of fluids to restore normovolaemia is one of the most common therapeutic interventions performed peri-operatively and in the critically ill, but no study has evaluated the importance of infusion rate for the plasma volume-expanding effect of a resuscitation fluid. The present study is designed to test the hypothesis that a slow infusion of resuscitation fluid results in better plasma volume expansion than a rapid infusion.The study is a single-centre, assessor-blinded, parallel-group, randomised prospective study. Patients over 40 years of age admitted to the post-operative care unit after a Whipple procedure or major gynaecological surgery and presenting with signs of hypovolaemia are eligible for inclusion. Patients are randomised in a 1:1 fashion with no stratification to either rapid (30 minutes) or slow (180 minutes) infusion of 5% albumin at a dose of 10 ml/kg ideal body weight. Plasma volume is measured using 125I human serum albumin at baseline (prior to albumin infusion) as well as at 30 minutes and 180 minutes after infusion start. The primary endpoint is change in plasma volume from baseline to 180 minutes after the start of 5% albumin infusion. Secondary endpoints include the integral of plasma volume over time from baseline to 180 minutes after the start of the infusion and transcapillary escape rate of albumin (%/h) from 180 minutes to 240 minutes after the start of albumin infusion. In addition, diuresis, change in central venous oxygen saturation, lactate and blood pressure will be evaluated. A total of 70 patients will be included in the study, and the study has 80% power to detect a difference of 4 ml/kg in plasma volume expansion between the two groups.The present study is the first clinical investigation of the importance of infusion rate for the plasma volume-expanding effect of a resuscitation fluid.EudraCT identifier: 2013-004446-42 . Registration date: 20 December 2013. ClinicalTrials.gov identifier: NCT02728921 . Registration date: 31 March 2016.

SUBMITTER: Statkevicius S

PROVIDER: S-EPMC5142270 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery - AIR: study protocol for a randomised controlled trial.

Statkevicius Svajunas S Bonnevier Johan J Bark Björn P BP Larsson Erik E Öberg Carl M CM Kannisto Päivi P Tingstedt Bobby B Bentzer Peter P

Trials 20161207 1

<h4>Background</h4>Administration of fluids to restore normovolaemia is one of the most common therapeutic interventions performed peri-operatively and in the critically ill, but no study has evaluated the importance of infusion rate for the plasma volume-expanding effect of a resuscitation fluid. The present study is designed to test the hypothesis that a slow infusion of resuscitation fluid results in better plasma volume expansion than a rapid infusion.<h4>Methods/design</h4>The study is a si ...[more]

PMID: 27923389

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Project description:BackgroundOptimal infusion rate of colloids in patients with suspected hypovolemia is unknown, and the primary objective of the present study was to test if plasma volume expansion by 5% albumin is greater if fluid is administered slowly rather than rapidly.MethodsPatients with signs of hypoperfusion after major abdominal surgery were randomized to intravenous infusion of 5% albumin at a dose of 10 ml/kg (ideal body weight) either rapidly (30 min) or slowly (180 min). Plasma volume was measured using radiolabeled albumin at baseline, at 30 min, and at 180 min after the start of infusion. Primary outcome was change in plasma volume from the start of infusion to 180 min after the start of infusion. Secondary outcomes included the change in the area under the plasma volume curve and transcapillary escape rate (TER) for albumin from 180 to 240 min after the start of albumin infusion.ResultsA total of 33 and 31 patients were included in the analysis in the slow and rapid groups, respectively. The change in plasma volume from the start of infusion to 180 min did not differ between the slow and rapid infusion groups (7.4 ± 2.6 vs. 6.5 ± 4.1 ml/kg; absolute difference, 0.9 ml/kg [95%CI, - 0.8 to 2.6], P = 0.301). Change in the area under the plasma volume curve was smaller in the slow than in the rapid infusion group and was 866 ± 341 and 1226 ± 419 min ml/kg, respectively, P < 0.001. TER for albumin did not differ and was 5.3 ± 3.1%/h and 5.4 ± 3%/h in the slow and in the rapid infusion groups, respectively, P = 0.931.ConclusionsThis study does not support our hypothesis that a slow infusion of colloid results in a greater plasma volume expansion than a rapid infusion. Instead, our result of a smaller change in the area under the plasma volume curve indicates that a slow infusion results in a less efficient plasma volume expansion, but further studies are required to confirm this finding. A rapid infusion has no effect on vascular leak as measured after completion of the infusion.Trial registrationEudraCT2013-004446-42 registered December 23, 2014.

Project description:BackgroundInflammatory response is one of the key components of pain perception. Continuous infusion (CWI) of local anesthetics has been shown to be effective in controlling pain and reducing postoperative morphine consumption, but the effect of adding a potent anti-inflammatory drug (such as a steroid) has never been addressed. In our study, we want to investigate the effect of CWI with local anesthetic + methylprednisolone on acute and persistent pain, correlating clinical data with biomarkers of inflammation and genetic background.Methods/designAfter approval by their institutional review board, three hospitals will enroll 120 patients undergoing major abdominal surgery in a randomized, double-blind, phase III study. After a 24-h CWI of ropivacaine 0.2 % + methylprednisolone 1 mg/kg, patients will be randomly assigned to receive either ropivacaine + steroid or placebo for the next 24 h. Then, patient-controlled CWI with only ropivacaine 0.2 % or placebo (according to the group of randomization) is planned after 48 h up to 7 days (bolus 10 ml, lock-out 1 h, maximum dose of 40 ml in 4 h). Morphine equivalent consumption up to 7 days will be analyzed, together with any catheter- or drug-related side effect. Persistent post-surgical pain (PPSP) incidence will also be investigated. Our primary endpoint is analgesic consumption in the first 7 days after surgery; we will evaluate, as secondary endpoints, any catheter- or drug-related side effect, genotype/phenotype correlations between some polymorphisms and postoperative outcome in terms of morphine consumption, development of the inflammatory response, and incidence of PPSP. Finally, we will collect, in a subgroup of patients, wound exudate samples by micro-dialysis, blood samples, and urine samples up to 72 h to investigate local and systemic inflammation and oxidative stress.DiscussionThis is a phase III trial to evaluate the safety and efficacy of wound infusion with steroid and local anesthetic. The study is aimed also to evaluate how long this infusion has to be maintained in order to maximize effectiveness. Our data are intended to quantify the amount of ropivacaine and methylprednisolone needed by patients undergoing major abdominal surgery, to be stored in a new nanotechnology device for sustained pain treatment after surgery. We also aim to clarify the roles of inflammatory response, oxidative stress, and genetic background on postoperative and persistent pain after major abdominal surgery.Trial registrationThe trial was registered on ClinicalTrials.gov ( NCT02002663 ) on 24 Oct. 2013.

Project description:BACKGROUND:Major abdominal surgery (MAS) is associated with increased morbidity and mortality. The main objective of our study was to evaluate the predictive value of heart-rate variability (HRV) concerning development of postoperative complications in patients undergoing MAS. The secondary objectives were to identify the relationship of HRV and use of vasoactive drugs during anesthesia, intensive care unit length of stay (ICU-LOS), and hospital length of stay (H-LOS). PATIENTS AND METHODS:Sixty-five patients scheduled for elective MAS were enrolled in a prospective, single-center, observational study. HRV was measured by spectral analysis (SA) preoperatively during orthostatic load. Patients were divided according to cardiac autonomic reactivity (CAR; n=23) and non-cardiac autonomic reactivity (NCAR; n=30). RESULTS:The final analysis included 53 patients. No significant difference was observed between the two groups regarding type of surgery, use of minimally invasive techniques or epidural catheter, duration of surgery and anesthesia, or the amount of fluid administered intraoperatively. The NCAR group had significantly greater intraoperative blood loss than the CAR group (541.7±541.9 mL vs 269.6±174.3 mL, p<0.05). In the NCAR group, vasoactive drugs were used during anesthesia more frequently (n=21 vs n=4; p<0.001), and more patients had at least one postoperative complication compared to the CAR group (n=19 vs n=4; p<0.01). Furthermore, the NCAR group had more serious complications (Clavien-Dindo ? Grade III n=6 vs n=0; p<0.05) and a greater number of complications than the CAR group (n=57 vs n=5; p<0.001). Significant differences were found for two specific subgroups of complications: hypotension requiring vasoactive drugs (NCAR: n=10 vs CAR: n=0; p<0.01) and ileus (NCAR: n=11 vs CAR: n=2; p<0.05). Moreover, significant differences were found in the ICU-LOS (NCAR: 5.7±3.5 days vs CAR: 2.6±0.7 days; p<0.0001) and H-LOS (NCAR: 12.2±5.6 days vs CAR: 7.2±1.7 days; p<0.0001). CONCLUSION:Preoperative HRV assessment during orthostatic load is objective and useful for identifying patients with low autonomic physiological reserves and high risk of poor post-operative course.

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The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery - AIR: study protocol for a randomised controlled trial.

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The importance of albumin infusion rate for plasma volume expansion following major abdominal surgery - AIR: study protocol for a randomised controlled trial.

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