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Study goal: This study will examine whether there is a significant difference in postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution.
Hypothesis: Perioperative fluid optimization through the use of a closed-loop assistance with a balanced starch solution (volulyte®) will be associated with a decrease in postoperative complications compared to the same approach using a balanced crystalloid solution (Plasmalyte®).
Objective: To establish which kind of intravenous fluid used for goal directed therapy with closed-loop assistance will reduce the number of postoperative complications (evaluation made by the POMS score).
Controversy still persists regarding the type of fluid to use in the operating room to avoid hypovolemia and any circulatory insufficiency. While crystalloids and colloid solutions are frequently used to optimize intravascular volume during surgery, crystalloid solutions require more volume for hemodynamic optimization which may result in higher volumes of fluid administration and potentially side effects. Compared with crystalloids, colloids have the advantages of remaining in the intravascular space longer, achieving faster circulatory stabilization, maintaining colloid osmotic pressure and increasing micro perfusion. However, colloids are more expensive and may have various side effects.
In addition to the effect of crystalloids and colloids on the patient, the amount of each fluid administered is also under debate. Goal-directed fluid therapy (GDFT) strategies based on cardiac output (CO) optimization have been shown to benefit moderate- to high-risk surgery patients and have recently been recommended by professional societies in the UK, in France, and in Europe. However, despite the growing evidence, these strategies are often not implemented in current practice. One of the reasons for this lack of implementation is that GDFT strategies, like any other complex clinical protocol, require significant provider attention and vigilance for consistent implementation and it is well known that even under study conditions protocol compliance rates are often not greater than 50% In another hand, one of the chief complicating factors in fluid administration studies is variation in provider administration practices, even when attempting to follow a protocol. Previous studies have used closed-loop (automated) systems to deliver fluid by a standardized protocol, removing variation between providers as one of the confounders of the study. Dr. Cannesson and Rinehart (UC Irvine, California, USA) have recently developed and used a closed-loop system for the provision of GDFT in clinical studies at UC Irvine and La Pitie hospital in France. The closed-loop system is beneficial because it involves the standardization of fluid management and all patients are treated equivalently. This system will thus provide consistent GDFT for all cases in the protocol and remove inter-provider variability as a confounder between groups.
Study goal: This study will examine whether there is a significant difference in postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution.
Hypothesis: Perioperative fluid optimization through the use of a closed-loop assistance with a balanced starch solution (volulyte®) will be associated with a decrease in postoperative complications compared to the same approach using a balanced crystalloid solution (Plasmalyte®).
Objective: To establish which kind of intravenous fluid used for goal directed therapy with closed-loop assistance will reduce the number of postoperative complications (evaluation made by the POMS score).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volulyte | Experimental | A baseline crystalloid infusion (plasmalyte®) will be set by the attending physician at 3 cc/kg/hr (standard patient care) for each of the randomized groups. The patient will receive fluid management via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to standardize the way fluids are administered intra-operatively and eliminate variation between clinical providers. The liquid perfused will be bolus amounts of volulyte. |
|
| Plasma-Lyte | Active Comparator | A baseline crystalloid infusion (plasmalyte®) will be set by the attending physician at 3 cc/kg/hr (standard patient care) for each of the randomized groups. The patient will receive fluid management via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to standardize the way fluids are administered intra-operatively and eliminate variation between clinical providers. The liquid perfused will be bolus amounts of plasma-lyte. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasmalyte | Drug |
| ||
| Volulyte |
| Measure | Description | Time Frame |
|---|---|---|
| POMS score | Difference between the 2 groups in postoperative morbidity identified with the Post-Operative Morbidity Survey (POMS score) on postoperative days 2. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate | Difference in 30-day post-operative mortality between the 2 groups | 30 days |
| Length of hospitalisation | Difference in duration of hospital length of stay as well as ICU length of stay. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amélie Delaporte, MD | CHU Brugmann | Principal Investigator |
| Alexandre Joosten, MD | Erasme | Principal Investigator |
| Philippe Van der Linden, MD, Pr | CHU Brugmann | Principal Investigator |
| Brigitte Ickx, Md, Pr | Erasme | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brugmann | Brussels | 1020 | Belgium | |||
| Erasme |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23112214 | Background | Feldheiser A, Pavlova V, Bonomo T, Jones A, Fotopoulou C, Sehouli J, Wernecke KD, Spies C. Balanced crystalloid compared with balanced colloid solution using a goal-directed haemodynamic algorithm. Br J Anaesth. 2013 Feb;110(2):231-40. doi: 10.1093/bja/aes377. Epub 2012 Oct 30. | |
| 24326085 | Background | Silva JM Jr, de Oliveira AM, Nogueira FA, Vianna PM, Pereira Filho MC, Dias LF, Maia VP, Neucamp Cde S, Amendola CP, Carmona MJ, Malbouisson LM. The effect of excess fluid balance on the mortality rate of surgical patients: a multicenter prospective study. Crit Care. 2013 Dec 10;17(6):R288. doi: 10.1186/cc13151. |
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| ID | Term |
|---|---|
| C048013 | Plasmalyte A |
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|
| every day up to 90 days after hospitalisation |
| Quantity of fluid administered during surgery | Fluid balance during surgery | 24 hours |
| Transfusion rate | Differences of transfusion rate between the two groups, in ml | 8 days |
| Hypotension incidence | Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure). | 8 days |
| Need of vasopressors | Difference in the need and quantity of vasopressors between the two groups | 24 hours |
| Mean case cardiac index (L /BSA) | Mean case cardiac index (L /BSA), Mean case cardiac stroke volume index (mL/ BSA). | 24 hours |
| Whodas scale | Enrolled patients will be contacted by phone and their quality of life assessed by the Whodas scale | 6 months after surgery |
| Whodas scale | Enrolled patients will be contacted by phone and their quality of life assessed by the Whodas scale | 1 year after surgery |
| Pruritus apparition | Enrolled patients will be contacted by phone 6 months after surgery and any pruritus apparition will be recorded | 6 months after surgery |
| Pruritus apparition | Enrolled patients will be contacted by phone 1 year after surgery and any pruritus apparition will be recorded | 1 year after surgery |
| Renal function - urea level | Urea levels. Measured in a blood sample taken according to the standard of care outpatient post-operative follow appointments. | 6 months after surgery |
| Renal function - urea level | Urea levels. Measured in a blood sample taken according to the standard of care outpatient post-operative follow appointments. | 1 year after surgery |
| Renal function - creatinine level | Creatinine levels. Measured in a blood sample taken according to the standard of care outpatient post-operative follow appointments. | 6 months after surgery |
| Renal function - creatinine level | Creatinine levels. Measured in a blood sample taken according to the standard of care outpatient post-operative follow appointments. | 1 year after surgery |
| Renal function - Estimated glomerular filtration rate (eGFR) | Creatinine levels. Measured in a blood sample taken according to the standard of care outpatient post-operative follow appointments. | 6 months after surgery |
| Renal function - Estimated glomerular filtration rate (eGFR) | Creatinine levels. Measured in a blood sample taken according to the standard of care outpatient post-operative follow appointments. | 1 year after surgery |
| Brussels |
| 1070 |
| Belgium |
| 22738085 | Background | Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Aneman A, Madsen KR, Moller MH, Elkjaer JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Soe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjaeldgaard AL, Fabritius ML, Mondrup F, Pott FC, Moller TP, Winkel P, Wetterslev J; 6S Trial Group; Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12;367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27. |
| 20022261 | Background | Cannesson M. Arterial pressure variation and goal-directed fluid therapy. J Cardiothorac Vasc Anesth. 2010 Jun;24(3):487-97. doi: 10.1053/j.jvca.2009.10.008. No abstract available. |
| 23264068 | Background | Ramsingh DS, Sanghvi C, Gamboa J, Cannesson M, Applegate RL 2nd. Outcome impact of goal directed fluid therapy during high risk abdominal surgery in low to moderate risk patients: a randomized controlled trial. J Clin Monit Comput. 2013 Jun;27(3):249-57. doi: 10.1007/s10877-012-9422-5. Epub 2012 Dec 22. |
| 24842135 | Background | Pearse RM, Harrison DA, MacDonald N, Gillies MA, Blunt M, Ackland G, Grocott MP, Ahern A, Griggs K, Scott R, Hinds C, Rowan K; OPTIMISE Study Group. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA. 2014 Jun 4;311(21):2181-90. doi: 10.1001/jama.2014.5305. |