Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery

• ClinicalTrials.gov Identifier: NCT03070080
• Recruitment Status: Completed
• First Posted: March 3, 2017
• Last Update Posted: May 9, 2018
• Sponsor: Assiut University
• Information provided by (Responsible Party): Khaled Abdel-Baky Abdel-Rahman, Assiut University

Tracking Information

• First Submitted Date: February 28, 2017
• First Posted Date: March 3, 2017
• Last Update Posted Date: May 9, 2018
• Actual Study Start Date: January 1, 2017
• Actual Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Fluid Therapy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 28, 2017): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 7, 2018
• Actual Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03070080
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Responsible Party: Khaled Abdel-Baky Abdel-Rahman, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Khaled A Abdel-Rahman, MD; Assiut University

• PRS Account: Assiut University
• Verification Date: March 2017