Safety and Efficacy of Adding Intravenous N-acetyl Cysteine in Colon Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-30

Study Completion Date

2016-10-15

Brief Summary

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The use of antioxidant agents in the prevention or decreasing the severity of postoperative systemic inflammatory response syndrome after colonic surgeries adopted nowadays. Therefore, it is of interest to investigate safety and efficacy of administrating short term intravenous (IV) N acetyl cysteine as add on to l alany l glutamine and total parenteral nutrition on the marker of oxidative stress malondialdehyde and anti- inflammatory marker tumor necrosis factor alpha in patients undergoing colonic surgeries through a prospective, randomized, double blinded, controlled clinical trial

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Detailed Description

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A prospective, randomized, double blinded, controlled clinical trial will be carried out on 60 patients, who will admit to the critical care unit, Ain Shams hospitals, Cairo, Egypt, following colon surgeries. Before the start of the study, eligible patients were randomized using computer generated list in order to allocate participants to either Group I (n acetyl cysteine group) or Group II (control group) in an equal manner No medication will take before the surgery and only oral fluids were allowed on the day before the operation. All eligible patients underwent bowel preparation with oral 1.745 g/ 30 ml magnesium citrate, and phosphate containing enema on the day before surgery. All patients received the general anesthesia with endotracheal intubation and muscle relaxant.

Data management and analysis were performed using the Statistical Package for Social Sciences (SPSS) software for Windows version 18

Conditions

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Systemic Inflammatory Response Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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N acetylcysteine group

N Acetyl L Cysteine IV bolus (100 mg/kg dissolved in dextrose5%) infused over 15 minutes, followed by continuous infusion of 50mg/kg/day dissolved in dextrose 5% starting 1hr before induction of anesthesia, and continued for 48 hours after operation

Group Type ACTIVE_COMPARATOR

N Acetyl L Cysteine

Intervention Type DRUG

100 mg/kg n acetyl cysteine dissolved in dextrose5%

placebo group

received equal volume of dextrose 5% administrated at the same rate and duration as in the study group as a placebo

Group Type PLACEBO_COMPARATOR

dextrose 5%

Intervention Type OTHER

Interventions

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N Acetyl L Cysteine

100 mg/kg n acetyl cysteine dissolved in dextrose5%

Intervention Type DRUG

dextrose 5%

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* need for ICU admission after colonic surgery
* requirement of total parenteral nutrition for at least 5 days due to failure of or contraindication for enteral nutrition
* signing a written informed consent.

Exclusion Criteria

* patients with persistent hemodynamic instability (systolic blood pressure \<80 mm Hg), renal impairment, hepatic insufficiency, severe or uncontrolled sepsis, persistent metabolic acidosis, head trauma,and heart failure
* any sensitivity to components of L-alanyl L-glutamine (Dipeptiven®, Fresenius Kabi, Germany) or N acetyl cysteine

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No