Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery
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|ClinicalTrials.gov Identifier: NCT03070080|
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fluid Therapy||Procedure: restrictive fluid strategy Procedure: conservative fluid strategy||Not Applicable|
The controversies include the type of fluid, the timing of administration and the volume administrated. Following much discussion and ongoing controversy on colloids versus crystalloids and the ideal composition of the various intravenous solutions, the main focus more recently has been on the volume of fluids.
Fluid therapy strategies have been developed and implemented in clinical practice over several decades. The data suggest that aggressive or liberal intraoperative fluid resuscitation is harmful during open abdominal operation, whereas a restrictive fluid protocol has better outcomes, including fewer postoperative complications and a shorter discharge time.
However, a restrictive fluid regimen has several limitations. Overly restricted or inadequate fluid administration may lead to insufficient intravascular volume, tissue hypoperfusion, cellular oxygenation impairment and potential organ dysfunction, prolonged recovery of bowel function, and impair tissue oxygenation, which might ultimately impair wound healing including healing of anastomosis.
Recently, the pleth-variability index (PVI) derived from respiratory variations in peripheral perfusion index (PI) has been suggested to be an effective dynamic indicator of fluid responsiveness. Different from other invasive dynamic indices, PVI provides clinicians with a numerical value obtained non-invasively. PVI is calculated as [(PI max - PI min)/PI max] X 100, where PI max and PI min represent the maximal and the minimal value, respectively, of the plethysmographic perfusion index (PI) over one respiratory cycle. PI is the ratio between pulsatile and non-pulsatile infrared light absorption from the pulse oximeter, and it is physiologically equivalent to the amplitude of the plethysmographic waveform. A PVI value of >13% before volume expansion discriminated between fluid responders and non responders with 81% sensitivity and 100% specificity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery: Hemodynamics and Kidney Function Outcomes|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||May 1, 2018|
|Actual Study Completion Date :||May 7, 2018|
Active Comparator: restrictive group
restrictive fluid strategy, 6 ml/kg/hour of lactated Ringer, during intraoperative period
Procedure: restrictive fluid strategy
restrictive lactated ringers as intraoperative fluid therapy in a dose of 6ml/kg/hour
Other Name: fluid therapy
Active Comparator: conservative group
conservative fluid strategy, 12 ml/kg/hour of lactated Ringer, during intraoperative period
Procedure: conservative fluid strategy
conservative lactated ringers as intraoperative fluid therapy in a dose of 12ml/kg/hour
Other Name: conservative fluid therapy
- Neutrophil Gelatinase-associated Lipocalin (NGAL) [ Time Frame: 24 hours postoperative ]NGAL is a renal biomarker for acute kidney injury
- mean arterial blood pressure [ Time Frame: intraoperative ]non invasive measurement of mean arterial blood pressure
- heart rate [ Time Frame: intraoperative ]measurement of heart rate from pulse oximetry
- pleth-variability index [ Time Frame: intraoperative ]derived from respiratory variations in peripheral perfusion index.
- incidence of bradycardia [ Time Frame: intraoperative ]bradycardia defined as heart rate less than 50 beat per minute
- incidence of hypotension [ Time Frame: intraoperative ]hypotension defined as systolic blood pressure less than 40% of baseline value
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070080
|Assiut Iniversity hospitals|
|Assiut, Egypt, 71516|
|Principal Investigator:||Khaled A Abdel-Rahman, MD||Assiut University|