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Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03070080
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : May 9, 2018
Information provided by (Responsible Party):
Khaled Abdel-Baky Abdel-Rahman, Assiut University

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.

Condition or disease Intervention/treatment Phase
Fluid Therapy Procedure: restrictive fluid strategy Procedure: conservative fluid strategy Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Neutrophil Gelatinase-associated Lipocalin (NGAL) [ Time Frame: 24 hours postoperative ]
    NGAL is a renal biomarker for acute kidney injury

Secondary Outcome Measures :
  1. mean arterial blood pressure [ Time Frame: intraoperative ]
    non invasive measurement of mean arterial blood pressure

  2. heart rate [ Time Frame: intraoperative ]
    measurement of heart rate from pulse oximetry

  3. pleth-variability index [ Time Frame: intraoperative ]
    derived from respiratory variations in peripheral perfusion index.

  4. incidence of bradycardia [ Time Frame: intraoperative ]
    bradycardia defined as heart rate less than 50 beat per minute

  5. incidence of hypotension [ Time Frame: intraoperative ]
    hypotension defined as systolic blood pressure less than 40% of baseline value

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03070080

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Assiut Iniversity hospitals
Assiut, Egypt, 71516
Sponsors and Collaborators
Assiut University
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Principal Investigator: Khaled A Abdel-Rahman, MD Assiut University
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Responsible Party: Khaled Abdel-Baky Abdel-Rahman, principal investigator, Assiut University Identifier: NCT03070080    
Other Study ID Numbers: 23140000178
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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