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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03589495
Enrollment
60
Registered
2018-07-18
Start date
2015-07-30
Completion date
2016-10-15
Last updated
2018-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Inflammatory Response Syndrome

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

Interventions

100 mg/kg n acetyl cysteine dissolved in dextrose5%

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
assessing a change in the level of tumor necrosis factor alpha (TNF alpha) as ant-inflammatory marker reflecting n acetyl cysteine efficacyVenous blood samples were obtained before surgery (baseline evaluation), and on day two after surgery for measuring changes in TNF ALPHATNF alpha was measured using ELISA technique
assessing a change in the level of malondialdehyde as antioxidant marker in the venous blood sample reflecting n acetyl cysteine efficacyVenous blood samples were obtained before surgery (baseline evaluation), and on day two after surgery for measuring changes in malondialdehyde levelmalondialdehyde was measured using colorimetric method for assay

Secondary

MeasureTime frameDescription
measuring safety of N acetyl cysteine (adverse effects)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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026