Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

Cairo University (CU)

Status: Unknown

Conditions: Intestinal Obstruction Fluid Management With Hypertonic Saline

Treatments: Drug: Hypertonic saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03741257

N-55-2018

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Group A

Active Comparator group

Description:

Received Hypertonic saline 3% as resuscitation fluid.

Treatment:

Drug: Hypertonic saline

Group B

Active Comparator group

Description:

Received Hypertonic saline 1.8% as resuscitation

Treatment:

Drug: Hypertonic saline