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0.9% Saline Versus Plasma-Lyte 148 for Intravenous Fluid Therapy

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0.9% SALINE VERSUS PLASMA-LYTE 148 FOR INTRAVENOUS FLUID THERAPY BY DR SUMEET KUMAR REDDY, MBCHB. A thesis submitted to the Victoria University of Wellington in fulfilment of the requirements for the degree of Doctor of Philosophy Victoria University of Wellington 2016 1 2 This thesis is dedicated to my parents (Dr C. K. Reddy and Dr Reeta Lochan Reddy) and my late grandparents (Mr D. L. Reddy, Mrs Rukhmani Reddy, Mr Ram Lochan and Mrs Padma Lochan) for their love and support. 3 1 Contents 2 Abstract ............................................................................................................................ 13 3 List of abbreviations ......................................................................................................... 17 4 Preface ............................................................................................................................. 21 5 Personal contribution and acknowledgments ................................................................. 23 6 Introduction ..................................................................................................................... 27 6.1 Background ................................................................................................................ 27 6.2 Crystalloid fluids ........................................................................................................ 27 6.3 Unbuffered/unbalanced crystalloids ........................................................................ 28 6.4 Buffered/balanced crystalloids ................................................................................. 31 6.5 Current literature that has compared 0.9% saline to buffered crystalloids in adult patients. ............................................................................................................................... 34 6.6 Evidence comparing the effects of renal function between unbuffered and buffered crystalloid fluid. .................................................................................................................... 35 6.7 Evidence comparing the influence on haemostasis and blood transfusion requirements between unbuffered and buffered crystalloid fluid ..................................... 45 6.8 Evidence comparing gastrointestinal effects of unbuffered and buffered crystalloid fluid ................................................................................................................................... 53 6.9 Current recommendations for the prescribing of intravenous fluids in hospitals ... 57 6.10 Summary of background information ................................................................... 57 7 Hypotheses ...................................................................................................................... 59 4 8 Study one: A multi-centre, cluster randomised, double cross over, feasibility trial investigating the effect of using 0.9% saline or Plasma-Lyte® 148 as fluid therapy in intensive care patients on the risk of developing acute kidney injury. .................................................. 61 8.1 Primary aim ............................................................................................................... 61 8.2 Secondary aims ......................................................................................................... 61 8.3 Tertiary aims .............................................................................................................. 62 8.4 Overview ................................................................................................................... 62 8.5 Study design .............................................................................................................. 62 8.6 Primary outcome ....................................................................................................... 63 8.6.1 Primary outcome justification ........................................................................... 65 8.7 Secondary outcomes ................................................................................................. 66 8.8 Study participants ..................................................................................................... 67 8.8.1 Inclusion criteria................................................................................................. 67 8.8.2 Exclusion criteria ................................................................................................ 67 8.9 Study treatments ....................................................................................................... 67 8.10 Data collection and Management ......................................................................... 69 8.11 Study medication and logistics .............................................................................. 72 8.12 Assessment of safety ............................................................................................. 72 8.13 Data safety monitoring board and monitoring ..................................................... 72 8.14 Ethical issues .......................................................................................................... 73 8.15 Process of obtaining opt-out consent ................................................................... 74 8.16 Data handling and confidentiality ......................................................................... 75 8.17 Sample size and power .......................................................................................... 75 5 8.18 Statistical analysis .................................................................................................. 76 8.19 Funding and support.............................................................................................. 77 8.20 Results .................................................................................................................... 78 8.20.1 Baseline characteristics ...................................................................................... 78 8.20.2 Fluid therapy ...................................................................................................... 84 8.20.3 Fluid therapy survey........................................................................................... 84 8.20.4 Primary outcome variable: the proportion of patients with either AKI or renal failure ............................................................................................................................ 88 8.20.5 Primary outcome variable: missing data sensitivity analysis ............................ 88 8.20.6 Secondary outcome variables: Renal outcomes ................................................ 90 8.20.7 Secondary outcome variables: Service utilisation ............................................. 92 8.20.8 Secondary outcome variables: Mortality ........................................................... 92 8.20.9 Primary and secondary outcomes variables: Adjusted analyses ....................... 94 8.20.10 Subgroup analyses: Renal outcomes ............................................................. 94 8.20.11 Subgroup analyses: In-hospital mortality ...................................................... 95 8.20.12 Protocol deviations ........................................................................................ 96 8.20.13 Adverse events ............................................................................................... 96 8.21 Discussion for study one ........................................................................................ 97 8.21.1 Statement of principal findings .......................................................................... 97 8.21.2 Significance of the findings ................................................................................ 97 8.21.3 Strengths and limitations ................................................................................... 98 8.21.4 Conclusions ...................................................................................................... 101 6 9 Study two: A post-hoc exploratory subgroup analysis and single centre pilot study nested cohort within study one to evaluate the effects of 0.9% saline and Plasma-Lyte-148 on blood product use and post-operative bleeding. ............................................................. 103 9.1 Rationale ................................................................................................................. 103 9.2 Primary aim ............................................................................................................. 104 9.3 Secondary aims ....................................................................................................... 105 9.4 Overview ................................................................................................................. 105 9.5 Study design and treatment allocation ................................................................... 106 9.5.1 Study design: Details of nested cohort ............................................................ 106 9.6 Primary outcome: Overall cohort ........................................................................... 107 9.7 Primary outcome: Nested cohort ........................................................................... 107 9.8 Secondary outcomes: Overall cohort ...................................................................... 108 9.9 Secondary outcomes: Nested cohort .....................................................................
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