Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

NCT03741257 | Unknown

• 1 other identifier: N-55-2018
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Rationale : Perioperative fluid management is a challenging issue in surgical care especially in a procedure specific model. Recently hypertonic saline (HS) has the advantage of using the patient's own total body water by drawing interstitial space. Although it still controversial whether HS is associated with benefits in specific patient populations, particularly with respect to site of lesion and illness severity; these data provide insight into therapeutic modalities to curtail ileus formation. Objectives :

• Measurement of total volume of fluid infused, the need of inotropic or vasopressor to maintain adequate hemodynamic parameters with assessment of electrolyte disturbances and S.lactate
• The incidence rate of surgical complications; infection and anastomotic dehiscence Study population \& Sample size : There were no previous trials comparing the two studied groups of the current trial. We expected a small standardized effect size of 0.2. Based on this effect size, 25 subjects will be needed to elicit the difference between the two groups at an alpha level of 0.05 and power of 0.9 (Whitehead et al; 2016).

Conditions

Intestinal Obstruction Fluid Management With Hypertonic Saline

Outcome Measures

Primary Outcomes (1)

• Total volume of infused fluids

  the total volume of fluids given to subjects intraoperatively and postoperatively

  24 hours

Secondary Outcomes (1)

• surgical complications rate

  4 days

Study Arms (2)

Group A

ACTIVE COMPARATOR

Received Hypertonic saline 3% as resuscitation fluid.

Drug: Hypertonic saline

Group B

ACTIVE COMPARATOR

Received Hypertonic saline 1.8% as resuscitation

Drug: Hypertonic saline

Interventions

Hypertonic saline DRUG

resuscitation fluid

Group A; Group B

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 20-70 years old
• ASA≤III
• BMI 25-40kg/m.

You may not qualify if:

• Severe CVS diseases (EF\<50%)
• Severe pulmonary diseases (Pulmonary function test ≤ 50% of predicted)
• Neurological disorders; Psychological diseases, demyelinating lesions, Parkinsonism, motor or sensory disorders.
• Pregnancy.
• Severe chronic renal disease (s. Creatinine\> 2gm/dl or patients on dialysis).
• Severe hepatic impairment (Child \& Pugh classification class C).
• Acid-base and electrolytes disturbances.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Hospitals

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Interventions

Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Rasha Behery, MD

CONTACT

+201228604556; rasha.behery.rz@gmail.com

Ahmed Lotfy, MD

CONTACT

+201000608905; ahmed.lotfy@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: November 11, 2018
• First Posted: November 14, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: February 1, 2020
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)