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

NCT03589495 | Completed Phase 4

• 1 other identifier: 79
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Systemic Inflammatory Response Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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)

Study Arms (2)

N acetylcysteine group

ACTIVE COMPARATOR

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

placebo group

PLACEBO COMPARATOR

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

Other: dextrose 5%

Interventions

N Acetyl L Cysteine DRUG

100 mg/kg n acetyl cysteine dissolved in dextrose5%

N acetylcysteine group

dextrose 5% OTHER

placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (1)

• Hamamsy ME, Bondok R, Shaheen S, Eladly GH. Safety and efficacy of adding intravenous N-acetylcysteine to parenteral L-alanyl-L-glutamine in hospitalized patients undergoing surgery of the colon: a randomized controlled trial. Ann Saudi Med. 2019 Jul-Aug;39(4):251-257. doi: 10.5144/0256-4947.2019.251. Epub 2019 Aug 5.

  PMID: 31381364 DERIVED

MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• manal elhammsy, prof

  Ain Shams University , faculty of pharmacy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, and clinical pharmacist in Ain Shams hospitals

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 18, 2018
• Study Start: July 30, 2015
• Primary Completion: October 15, 2016
• Study Completion: October 15, 2016
• Last Updated: July 18, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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