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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
Sponsor:
Information provided by (Responsible Party):
Khaled Abdel-Baky Abdel-Rahman, Assiut University

Tracking Information
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
 (submitted: March 4, 2017)
Neutrophil Gelatinase-associated Lipocalin (NGAL) [ Time Frame: 24 hours postoperative ]
NGAL is a renal biomarker for acute kidney injury
Original Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
Neutrophil Gelatinase-associated Lipocalin (NGAL) [ Time Frame: preoperative, 2 hours postoperative and 24 hours postoperative ]
NGAL is a renal biomarker for acute kidney injury
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • mean arterial blood pressure [ Time Frame: intraoperative and 24 hours postoperative ]
    non invasive measurement of mean arterial blood pressure
  • heart rate [ Time Frame: intraoperative and 24 hours postoperative ]
    measurement of heart rate from pulse oximetry
  • plethvariability index [ Time Frame: intraoperative ]
    derived from respiratory variations in peripheral perfusion index.
  • incidence of bradycardia [ Time Frame: intraoperaitve ]
    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
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.

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
Condition  ICMJE Fluid Therapy
Intervention  ICMJE
  • Procedure: restrictive fluid strategy
    restrictive lactated ringers as intraoperative fluid therapy in a dose of 6ml/kg/hour
    Other Name: fluid therapy
  • Procedure: conservative fluid strategy
    conservative lactated ringers as intraoperative fluid therapy in a dose of 12ml/kg/hour
    Other Name: conservative fluid therapy
Study Arms  ICMJE
  • Active Comparator: restrictive group
    restrictive fluid strategy, 6 ml/kg/hour of lactated Ringer, during intraoperative period
    Intervention: Procedure: restrictive fluid strategy
  • Active Comparator: conservative group
    conservative fluid strategy, 12 ml/kg/hour of lactated Ringer, during intraoperative period
    Intervention: Procedure: conservative fluid strategy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2017)
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:

  1. Adult patients scheduled for colorectal surgery
  2. American Society of Anesthesiologists grade I-II.

Exclusion criteria:

  1. patient refusal.
  2. psychiatric disorders.
  3. pregnancy and lactation.
  4. preexisting neurological dysfunction ( history of cerebrovascular stroke CVS)
  5. Allergy to any protocol medication.
  6. metastatic cancer.
  7. Inflammatory bowel disease.
  8. Coronary artery disease with impaired cardiac function.
  9. Diabetes mellitus.
  10. Renal insufficiency (serum creatinine level more than 180 μmol/l).
  11. unexpected intraoperative findings (small bowel obstruction, inoperable).
  12. accidental massive intraoperative haemorrhage.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Khaled Abdel-Baky Abdel-Rahman, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Khaled A Abdel-Rahman, MD Assiut University
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