A pragmatic multi-centre randomised controlled trial of fluid loading in high-risk surgical patients undergoing major elective surgery - the FOCCUS study

被引:10
作者
Cuthbertson, Brian H. [1 ,2 ]
Campbell, Marion K. [2 ]
Stott, Stephen A. [3 ]
Elders, Andrew [2 ]
Hernandez, Rodolfo [2 ,4 ]
Boyers, Dwayne [4 ]
Norrie, John [2 ]
Kinsella, John [5 ]
Brittenden, Julie [6 ]
Cook, Jonathan [2 ]
Rae, Daniela [2 ]
Cotton, Seonaidh C. [2 ]
Alcorn, David [7 ]
Addison, Jennifer [2 ]
Grant, Adrian [8 ]
机构
[1] Sunnybrook Hlth Sci Ctr, Dept Crit Care Med, Toronto, ON M4N 3M5, Canada
[2] Univ Aberdeen, Hlth Serv Res Unit, Aberdeen AB25 2ZD, Scotland
[3] Aberdeen Royal Infirm, Intens Care Unit, Aberdeen AB25 2ZN, Scotland
[4] Univ Aberdeen, Hlth Econ Res Unit, Aberdeen AB25 2ZD, Scotland
[5] Univ Glasgow, Glasgow Royal Infirm, Sect Anaesthesia Pain & Crit Care, Glasgow G31 2HT, Lanark, Scotland
[6] Univ Aberdeen, Dept Surg, Aberdeen AB25 2ZD, Scotland
[7] Royal Alexandra Hosp, Paisley PA2 9PN, Strathclyde, Scotland
[8] Univ Aberdeen, Kings Coll, Inst Appl Hlth Sci, Aberdeen AB24 3FX, Scotland
来源
CRITICAL CARE | 2011年 / 15卷 / 06期
关键词
surgery; peri-operative management; fluid therapy; outcome; morbidity; optimisation; HOSPITAL STAY; PREOPERATIVE OPTIMIZATION; CLINICAL-TRIAL; MANAGEMENT; THERAPY; COMPLICATIONS; MORTALITY; METAANALYSIS; DOPEXAMINE;
D O I
10.1186/cc10592
中图分类号
R4 [临床医学];
学科分类号
1002 ; 100602 ;
摘要
Introduction: Fluid strategies may impact on patient outcomes in major elective surgery. We aimed to study the effectiveness and cost-effectiveness of pre-operative fluid loading in high-risk surgical patients undergoing major elective surgery. Methods: This was a pragmatic, non-blinded, multi-centre, randomised, controlled trial. We sought to recruit 128 consecutive high-risk surgical patients undergoing major abdominal surgery. The patients underwent pre-operative fluid loading with 25 ml/kg of Ringer's solution in the six hours before surgery. The control group had no pre-operative fluid loading. The primary outcome was the number of hospital days after surgery with cost-effectiveness as a secondary outcome. Results: A total of 111 patients were recruited within the study time frame in agreement with the funder. The median pre-operative fluid loading volume was 1,875 ml (IQR 1,375 to 2,025) in the fluid group compared to 0 (IQR 0 to 0) in controls with days in hospital after surgery 12.2 (SD 11.5) days compared to 17.4 (SD 20.0) and an adjusted mean difference of 5.5 days (median 2.2 days; 95% CI -0.44 to 11.44; P = 0.07). There was a reduction in adverse events in the fluid intervention group (P = 0.048) and no increase in fluid based complications. The intervention was less costly and more effective (adjusted average cost saving: 2,047; pound adjusted average gain in benefit: 0.0431 quality adjusted life year (QALY)) and has a high probability of being cost-effective. Conclusions: Pre-operative intravenous fluid loading leads to a non-significant reduction in hospital length of stay after high-risk major surgery and is likely to be cost-effective. Confirmatory work is required to determine whether these effects are reproducible, and to confirm whether this simple intervention could allow more cost-effective delivery of care. Trial registration: Prospective Clinical Trials, ISRCTN32188676
引用
收藏
页数:12
相关论文
共 33 条
  • [1] Wet, dry or something else?
    Bellamy, M. C.
    [J]. BRITISH JOURNAL OF ANAESTHESIA, 2006, 97 (06) : 755 - 757
  • [2] The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery
    Bennett-Guerrero, E
    Welsby, I
    Dunn, TJ
    Young, LR
    Wahl, TA
    Diers, TL
    Phillips-Bute, BG
    Newman, MF
    Mythen, MG
    [J]. ANESTHESIA AND ANALGESIA, 1999, 89 (02) : 514 - 519
  • [3] A RANDOMIZED CLINICAL-TRIAL OF THE EFFECT OF DELIBERATE PERIOPERATIVE INCREASE OF OXYGEN DELIVERY ON MORTALITY IN HIGH-RISK SURGICAL PATIENTS
    BOYD, O
    GROUNDS, RM
    BENNETT, ED
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1993, 270 (22): : 2699 - 2707
  • [4] Effects of intravenous fluid restriction on postoperative complications: Comparison of two perioperative fluid regimens - A randomized assessor-blinded multicenter trial
    Brandstrup, B
    Tonnesen, H
    Beier-Holgersen, R
    Hjortso, E
    Ording, H
    Lindorff-Larsen, K
    Rasmussen, MS
    Lanng, C
    Wallin, L
    Iversen, LH
    Gramkow, CS
    Okholm, M
    Blemmer, T
    Svendsen, PE
    Rottensten, HH
    Thage, B
    Riis, J
    Jeppesen, IS
    Teilum, D
    Christensen, AM
    Graungaard, B
    Pott, F
    [J]. ANNALS OF SURGERY, 2003, 238 (05) : 641 - 648
  • [5] Briggs AH., 1999, HEALTH TECHNOL ASSES, V3, P1, DOI [10.3310/hta3020, DOI 10.3310/HTA3020]
  • [6] Relationship between stroke volume, cardiac output and filling of the heart during tilt
    Bundgaard-Nielsen, M.
    Sorensen, H.
    Dalsgaard, M.
    Rasmussen, P.
    Secher, N. H.
    [J]. ACTA ANAESTHESIOLOGICA SCANDINAVICA, 2009, 53 (10) : 1324 - 1328
  • [7] 'Liberal' vs. 'restrictive' perioperative fluid therapy - a critical assessment of the evidence
    Bundgaard-Nielsen, M.
    Secher, N. H.
    Kehlet, H.
    [J]. ACTA ANAESTHESIOLOGICA SCANDINAVICA, 2009, 53 (07) : 843 - 851
  • [8] COPELAND GP, 1991, BRIT J SURG, V78, P356
  • [9] Curtis L., PERSONAL SOCIAL SERV
  • [10] A pragmatic multi-centre randomised controlled trial of fluid loading and level of dependency in high-risk surgical patients undergoing major elective surgery: trial protocol
    Cuthbertson, Brian H.
    Campbell, Marion K.
    Stott, Stephen A.
    Vale, Luke
    Norrie, John
    Kinsella, John
    Cook, Jonathan
    Brittenden, Julie
    Grant, Adrian
    [J]. TRIALS, 2010, 11