Restrictive Versus Conservative Fluid Therapy in Colorectal Surgery

NCT03070080 | Completed DMC

• 1 other identifier: 23140000178
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluid Therapy

Outcome Measures

Primary Outcomes (1)

• Neutrophil Gelatinase-associated Lipocalin (NGAL)

  NGAL is a renal biomarker for acute kidney injury

  24 hours postoperative

Secondary Outcomes (5)

• mean arterial blood pressure

  intraoperative

• heart rate

  intraoperative

• pleth-variability index

  intraoperative

• incidence of bradycardia

  intraoperative

• incidence of hypotension

  intraoperative

Study Arms (2)

restrictive group

ACTIVE COMPARATOR

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

Procedure: restrictive fluid strategy

conservative group

ACTIVE COMPARATOR

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

Procedure: conservative fluid strategy

Interventions

restrictive fluid strategy PROCEDURE

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

Also known as: fluid therapy

restrictive group

conservative fluid strategy PROCEDURE

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

Also known as: conservative fluid therapy

conservative group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Iniversity hospitals

Asyut, 71516, Egypt

Location

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Khaled A Abdel-Rahman, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 7, 2018
• Last Updated: May 9, 2018

Record last verified: 2017-03

Locations

EG (1)