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

• Status: Completed
• Trial end date: 2016-10-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Acetylcysteine; N-monoacetylcystine

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