Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery

NCT ID: NCT03070080

Last Updated: 2018-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-05-07

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.

Conditions

Fluid Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

restrictive group

restrictive fluid strategy, 6 ml/kg/hour of lactated Ringer, during intraoperative period

Group Type: ACTIVE_COMPARATOR

restrictive fluid strategy

Intervention Type: PROCEDURE

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

conservative group

conservative fluid strategy, 12 ml/kg/hour of lactated Ringer, during intraoperative period

Group Type: ACTIVE_COMPARATOR

conservative fluid strategy

Intervention Type: PROCEDURE

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

Interventions

restrictive fluid strategy

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

Intervention Type: PROCEDURE

conservative fluid strategy

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

Intervention Type: PROCEDURE

Other Intervention Names

fluid therapy; conservative fluid therapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Khaled Abdel-Baky Abdel-Rahman

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khaled A Abdel-Rahman, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut Iniversity hospitals

Asyut, , Egypt

Countries

Egypt

Other Identifiers

23140000178

Identifier Type: -

Identifier Source: org_study_id