Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery

Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery: Hemodynamics and Kidney Function Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Fluid Therapy
• Intervention / Treatment: Procedure: restrictive fluid strategy; Procedure: conservative fluid strategy

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71516
    • Assiut Iniversity hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: conservative fluid therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutrophil Gelatinase-associated Lipocalin (NGAL)	NGAL is a renal biomarker for acute kidney injury	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean arterial blood pressure	non invasive measurement of mean arterial blood pressure	intraoperative
heart rate	measurement of heart rate from pulse oximetry	intraoperative
pleth-variability index	derived from respiratory variations in peripheral perfusion index.	intraoperative
incidence of bradycardia	bradycardia defined as heart rate less than 50 beat per minute	intraoperative
incidence of hypotension	hypotension defined as systolic blood pressure less than 40% of baseline value	intraoperative

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): May 1, 2018
• Study Completion (ACTUAL): May 7, 2018

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (ACTUAL): March 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2018
• Last Update Submitted That Met QC Criteria: May 8, 2018
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 23140000178

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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