Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery

Fluid Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03070080
• Other study ID #: 23140000178
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: May 7, 2018

Study information

• Verified date: March 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 7, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Therapy

Intervention

Procedure:
• restrictive fluid strategy
restrictive lactated ringers as intraoperative fluid therapy in a dose of 6ml/kg/hour
• conservative fluid strategy
conservative lactated ringers as intraoperative fluid therapy in a dose of 12ml/kg/hour

Locations

Country	Name	City	State
Egypt	Assiut Iniversity hospitals	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neutrophil Gelatinase-associated Lipocalin (NGAL)	NGAL is a renal biomarker for acute kidney injury	24 hours postoperative
Secondary	mean arterial blood pressure	non invasive measurement of mean arterial blood pressure	intraoperative
Secondary	heart rate	measurement of heart rate from pulse oximetry	intraoperative
Secondary	pleth-variability index	derived from respiratory variations in peripheral perfusion index.	intraoperative
Secondary	incidence of bradycardia	bradycardia defined as heart rate less than 50 beat per minute	intraoperative
Secondary	incidence of hypotension	hypotension defined as systolic blood pressure less than 40% of baseline value	intraoperative