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Completed

NCT Number: NCT03589495

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

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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Key information

Conditions

Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N Acetyl L Cysteine

Drug

100 mg/kg n acetyl cysteine dissolved in dextrose5%

dextrose 5%

Other

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 18, 2018
Registry last updated
Jul 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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