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Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03070080
Enrollment
60
Registered
2017-03-03
Start date
2017-01-01
Completion date
2018-05-07
Last updated
2018-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Therapy

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.

Interventions

PROCEDURErestrictive fluid strategy

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

PROCEDUREconservative fluid strategy

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Neutrophil Gelatinase-associated Lipocalin (NGAL)24 hours postoperativeNGAL is a renal biomarker for acute kidney injury

Secondary

MeasureTime frameDescription
mean arterial blood pressureintraoperativenon invasive measurement of mean arterial blood pressure
heart rateintraoperativemeasurement of heart rate from pulse oximetry
pleth-variability indexintraoperativederived from respiratory variations in peripheral perfusion index.
incidence of bradycardiaintraoperativebradycardia defined as heart rate less than 50 beat per minute
incidence of hypotensionintraoperativehypotension defined as systolic blood pressure less than 40% of baseline value

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026