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

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ClinicalTrials.gov Identifier: NCT03589495
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
Ghada Hussein, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Systemic Inflammatory Response Syndrome Drug: N Acetyl L Cysteine Other: dextrose 5% Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Adding Intravenous N-acetyl Cysteine to Parenteral L-alanyl L-glutamine in Hospitalized Patients Undergoing Colon Surgeries
Actual Study Start Date : July 30, 2015
Actual Primary Completion Date : October 15, 2016
Actual Study Completion Date : October 15, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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
Drug: N Acetyl L Cysteine
100 mg/kg n acetyl cysteine dissolved in dextrose5%

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



Primary Outcome Measures :
  1. assessing a change in the level of tumor necrosis factor alpha (TNF alpha) as ant-inflammatory marker reflecting n acetyl cysteine efficacy [ Time Frame: Venous blood samples were obtained before surgery (baseline evaluation), and on day two after surgery for measuring changes in TNF ALPHA ]
    TNF alpha was measured using ELISA technique

  2. assessing a change in the level of malondialdehyde as antioxidant marker in the venous blood sample reflecting n acetyl cysteine efficacy [ Time Frame: Venous blood samples were obtained before surgery (baseline evaluation), and on day two after surgery for measuring changes in malondialdehyde level ]
    malondialdehyde was measured using colorimetric method for assay


Secondary Outcome Measures :
  1. measuring safety of N acetyl cysteine (adverse effects) [ Time Frame: from the beginning of the study till the patient is discharged from the hospital(up to one week) ]
    recording any adverse effects that may appear



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589495


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: manal elhammsy, prof Ain Shams University , faculty of pharmacy

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ghada Hussein, Principal Investigator, and clinical pharmacist in Ain Shams hospitals, Ain Shams University
ClinicalTrials.gov Identifier: NCT03589495     History of Changes
Other Study ID Numbers: 79
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All the individual participant data will be stored on the computer and will be available on request only
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: it will be available once the trial ends, and for 3 months after publication
Access Criteria: data will be available on request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes