title: Restrictive versus Standard Fluid Regimen in Elective Minilaparotomy Abdominal Aortic Repair-Prospective Randomized Controlled Trial.
abstract: Objective Elective minilaparotomy abdominal aortic aneurysm (AAA) repair is associated with a significant number of complications involving respiratory, cardiovascular, gastrointestinal, and central nervous systems, with mortality ranging up to 5%. In our study, we tested the hypothesis that intra- and postoperative intravenous restrictive fluid regimen reduces postoperative morbidity and mortality, and improves the outcome of minilaparotomy AAA repair. Methods From March 2009 to July 2013, 60 patients operated due to AAA were included in a prospective randomized controlled trial (RCT). About the administration of fluid during the operation and in the early postoperative period, all the patients were randomized into two groups: the group of standard fluid administration (S-group, 30 patients) and the group of reduced fluid administration (R-group, 30 patients). The verification of the treatment success was measured by the length of intensive care unit (ICU) stay, duration of hospitalization after the procedure, as well as the number and type of postoperative complications and mortality. This prospective RCT was registered in a publicly accessible database ClinicalTrials.gov with unique Identifier ID: NTC01939652. Results Total fluid administration and administration of blood products were significantly lower in R-group as compared with S-group (2,445.5 mL vs. 3308.7 mL, p = 0.004). Though the number of nonlethal complications was significantly lower in R-group (2 vs. 9 patients, p = 0.042), the difference in lethal complications remained nonsignificant (0 vs. 1 patient, p = ns). The average ICU stay (1.2 vs. 1.97 days, p = 0.003) and duration of postoperative hospital stay (4.33 vs. 6.20 days, p = 0.035 for R-group and S-group, respectively) were found to be significantly shorter in R-group. Conclusion Intra- and postoperative restrictive intravenous fluid regimen in patients undergoing minilaparotomy AAA repair significantly reduces postoperative morbidity, and shortens ICU and overall hospital stay. Even though incidence of lethal complication was lower in R-group, the difference did not reach statistical significance. Therefore, we may assume that this study was probably underpowered to estimate the differences in mortality between R- and S-groups. Further multicentric, sufficiently powered RCTs are needed to confirm these findings and to clarify effect of restrictive fluid management on mortality.
authors.affiliation: University of Tuzla School of Medicine, Department of Cardiovascular Surgery, University Clinical Center Tuzla, Tuzla, Bosnia and Herzegovina.
authors.forename: Dragan
authors.initials: D
authors.lastname: Piljic
authors.affiliation: University of Zagreb School of Medicine, Department of Cardiac Surgery, University Hospital Center Rebro, Zagreb, Croatia.
authors.forename: Mate
authors.initials: M
authors.lastname: Petricevic
authors.affiliation: University of Tuzla School of Medicine, University Clinical Center Tuzla, Tuzla, Bosnia and Herzegovina.
authors.forename: Dilista
authors.initials: D
authors.lastname: Piljic
authors.affiliation: University of Ljubljana School of Medicine, Department of Cardiovascular Surgery, University Clinical Center Ljubljana, Ljubljana, Slovenia.
authors.forename: Jus
authors.initials: J
authors.lastname: Ksela
authors.affiliation: Department of Cardiothoracic Surgery, Jessa Hospital, Hasselt, Belgium.
authors.forename: Boris
authors.initials: B
authors.lastname: Robic
authors.affiliation: University of Ljubljana School of Medicine, Department of Cardiovascular Surgery, University Clinical Center Ljubljana, Ljubljana, Slovenia.
authors.forename: Tomislav
authors.initials: T
authors.lastname: Klokocovnik
mesh_terms: D000368:Aged; D017544:Aortic Aneurysm, Abdominal / Q000000981:diagnostic imaging / Q000401:mortality / Q000601:surgery*; D001803:Blood Transfusion; D017522:Bosnia and Herzegovina; D017558:Elective Surgical Procedures; D005260:Female; D005440:Fluid Therapy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D006801:Humans; D007262:Infusions, Intravenous; D007813:Laparotomy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D011446:Prospective Studies; D012307:Risk Factors; D017524:Slovenia; D013997:Time Factors; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000379:methods* / Q000401:mortality