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
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Tracking Information | |||||||
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First Submitted Date ICMJE | February 28, 2017 | ||||||
First Posted Date ICMJE | March 3, 2017 | ||||||
Last Update Posted Date | May 9, 2018 | ||||||
Actual Study Start Date ICMJE | January 1, 2017 | ||||||
Actual Primary Completion Date | May 1, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Neutrophil Gelatinase-associated Lipocalin (NGAL) [ Time Frame: 24 hours postoperative ] NGAL is a renal biomarker for acute kidney injury
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Original Primary Outcome Measures ICMJE |
Neutrophil Gelatinase-associated Lipocalin (NGAL) [ Time Frame: preoperative, 2 hours postoperative and 24 hours postoperative ] NGAL is a renal biomarker for acute kidney injury
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery | ||||||
Official Title ICMJE | Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery: Hemodynamics and Kidney Function Outcomes | ||||||
Brief Summary | Fluid administration during and after surgery is an essential part of postoperative care to maintain the patients' fluid and biochemical balance. Abdominal surgical procedures are associated with dehydration from preoperative fasting, bowel preparation, and intra- and postoperative fluid and electrolyte loss. So, perioperative fluid management has been a topic of much debate over years and has intensified especially over the past several years. | ||||||
Detailed Description | 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Fluid Therapy | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
60 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | May 7, 2018 | ||||||
Actual Primary Completion Date | May 1, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Egypt | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03070080 | ||||||
Other Study ID Numbers ICMJE | 23140000178 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Khaled Abdel-Baky Abdel-Rahman, Assiut University | ||||||
Study Sponsor ICMJE | Assiut University | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Assiut University | ||||||
Verification Date | March 2017 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |