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Completed

NCT Number: NCT03070080

Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut Iniversity hospitals

Asyut, 71516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patient refusal.
  • psychiatric disorders.
  • pregnancy and lactation.
  • preexisting neurological dysfunction ( history of cerebrovascular stroke CVS)
  • Allergy to any protocol medication.
  • metastatic cancer.
  • Inflammatory bowel disease.
  • Coronary artery disease with impaired cardiac function.
  • Diabetes mellitus.
  • Renal insufficiency (serum creatinine level more than 180 μmol/l).
  • unexpected intraoperative findings (small bowel obstruction, inoperable).
  • accidental massive intraoperative haemorrhage.

Treatment and study plan

restrictive fluid strategy

Procedure

restrictive lactated ringers as intraoperative fluid therapy in a dose of 6ml/kg/hour

Other names: fluid therapy

conservative fluid strategy

Procedure

conservative lactated ringers as intraoperative fluid therapy in a dose of 12ml/kg/hour

Other names: conservative fluid therapy

Primary outcomes

  1. Neutrophil Gelatinase-associated Lipocalin (NGAL)

    Time frame: 24 hours postoperative

    NGAL is a renal biomarker for acute kidney injury

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2017
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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