Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03741257

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Intestinal Obstruction Fluid Management With Hypertonic Saline	Drug: Hypertonic saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Hypertonic Saline 3% Compared to Hypertonic Saline 1.8% for Fluid Management of Intestinal Obstruction Surgery

Actual Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Nov 1, 2019

Anticipated Study Completion Date :

Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A Received Hypertonic saline 3% as resuscitation fluid.	Drug: Hypertonic saline resuscitation fluid
Active Comparator: Group B Received Hypertonic saline 1.8% as resuscitation	Drug: Hypertonic saline resuscitation fluid

Arm

Intervention/Treatment

Active Comparator: Group A

Received Hypertonic saline 3% as resuscitation fluid.

Drug: Hypertonic saline

resuscitation fluid

Active Comparator: Group B

Received Hypertonic saline 1.8% as resuscitation

Drug: Hypertonic saline

resuscitation fluid

Outcome Measures

Primary Outcome Measures

Total volume of infused fluids [24 hours]
the total volume of fluids given to subjects intraoperatively and postoperatively

Secondary Outcome Measures

surgical complications rate [4 days]
the rate of surgical complications i.e leakage and wound dehisence

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University Hospitals	Cairo		Egypt	11562

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Lotfy, lecturer of anesthesia and intensive care, Cairo University

ClinicalTrials.gov Identifier:

NCT03741257

Other Study ID Numbers:

N-55-2018

First Posted:

Nov 14, 2018

Last Update Posted:

Nov 14, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intestinal Obstruction

Study Results

No Results Posted as of Nov 14, 2018