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

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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

Official Title
-----------------
Safety and Efficacy of Adding Intravenous N-acetyl Cysteine to Parenteral L-alanyl L-glutamine in Hospitalized Patients Undergoing Colon Surgeries

Conditions
-----------------
Systemic Inflammatory Response Syndrome

Intervention / Treatment
-----------------
* Drug: N Acetyl L Cysteine
* Other: dextrose 5%


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N acetylcysteine group<br>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 | Drug: N Acetyl L Cysteine<br>* 100 mg/kg n acetyl cysteine dissolved in dextrose5%<br>|
| Placebo Comparator: placebo group<br>received equal volume of dextrose 5% administrated at the same rate and duration as in the study group as a placebo | Other: dextrose 5%<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing a change in the level of tumor necrosis factor alpha (TNF alpha) as ant-inflammatory marker reflecting n acetyl cysteine efficacy | TNF alpha was measured using ELISA technique | Venous blood samples were obtained before surgery (baseline evaluation), and on day two after surgery for measuring changes in TNF ALPHA | 
| assessing a change in the level of malondialdehyde as antioxidant marker in the venous blood sample reflecting n acetyl cysteine efficacy | malondialdehyde was measured using colorimetric method for assay | Venous blood samples were obtained before surgery (baseline evaluation), and on day two after surgery for measuring changes in malondialdehyde level | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring safety of N acetyl cysteine (adverse effects) | recording any adverse effects that may appear | from the beginning of the study till the patient is discharged from the hospital(up to one week) |