Prevention of Cefoperazone-induced Coagulopathy

NCT05742295 | Completed Phase 4

• 1 other identifier: Vit. K for SULBinCo
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluating the effect of prophylactic doses of vitamin K in preventing the adverse effect of cefoperazone/sulbactam induced coagulopathy in critically ill patients.

Conditions

Antibiotic Side Effect

Keywords

Coagulopathy; Cefoperazone; Vitamin K; Cefoperazone/sulbactam

Outcome Measures

Primary Outcomes (1)

• Number of Participants with changes in INR level

  comparing INR level between baseline INR (before starting the antibiotic) and during the treatment with the antibiotic

  During the duration of cefoperazone/sulbactam treatment up to 2 weeks

Secondary Outcomes (1)

• Number of Participants with bleeding incidence

  During the duration of cefoperazone/sulbactam treatment up to 2 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

vitamin K is used as a prophylactic dose to prevent cefoperazone/sulbactam coagulopathy.

Drug: Vitamin K

Control group

NO INTERVENTION

Interventions

Vitamin K DRUG

Coadministration of vitamin K with the first dose of cefoperazone/sulbactam

Intervention group

Eligibility Criteria

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

You may qualify if:

• ICU admitted patients on treatment or prophylactic doses of cefoperazone/sulbactam.

You may not qualify if:

• Patients' aged \<18 years
• Pregnancy or breastfeeding women
• Active bleeding or bleeding disorder
• Patients having an abnormal baseline coagulation profile.
• Patients administer total parenteral nutrition with regular vitamin k supplements.
• Refusal to sign the written informed consent.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

6-October Hospital

Giza, Egypt

Location

Related Publications (11)

• Cai Z, Yang W, He Y, Chen Q, Wang S, Luo X, Wang X. Cefoperazone/Sulbactam-Induced Abdominal Wall Hematoma and Upper Gastrointestinal Bleeding: A Case Report and Review of the Literature. Drug Saf Case Rep. 2016 Dec;3(1):2. doi: 10.1007/s40800-016-0025-9.

  PMID: 27747682 BACKGROUND

• Schentag JJ, Welage LS, Grasela TH, Adelman MH. Determinants of antibiotic-associated hypoprothrombinemia. Pharmacotherapy. 1987;7(3):80-6. doi: 10.1002/j.1875-9114.1987.tb03522.x.

  PMID: 3306622 BACKGROUND

• Schentag JJ, Welage LS, Williams JS, Wilton JH, Adelman MH, Rigan D, Grasela TH. Kinetics and action of N-methylthiotetrazole in volunteers and patients. Population-based clinical comparisons of antibiotics with and without this moiety. Am J Surg. 1988 May 31;155(5A):40-4. doi: 10.1016/s0002-9610(88)80210-1.

  PMID: 3163900 BACKGROUND

• Allison PM, Mummah-Schendel LL, Kindberg CG, Harms CS, Bang NU, Suttie JW. Effects of a vitamin K-deficient diet and antibiotics in normal human volunteers. J Lab Clin Med. 1987 Aug;110(2):180-8.

  PMID: 3598347 BACKGROUND

• Mendes R, Policarpo S, Fortuna P, Alves M, Virella D, Heyland DK; Portuguese NUTRIC Study Group. Nutritional risk assessment and cultural validation of the modified NUTRIC score in critically ill patients-A multicenter prospective cohort study. J Crit Care. 2017 Feb;37:45-49. doi: 10.1016/j.jcrc.2016.08.001. Epub 2016 Aug 10.

  PMID: 27621112 BACKGROUND

• Fouda R, Soliman MS, ElAnany MG, Abadeer M, Soliman G. Prevalence and risk factors of MRSA, ESBL and MDR bacterial colonization upon admission to an Egyptian medical ICU. J Infect Dev Ctries. 2016 Apr 28;10(4):329-36. doi: 10.3855/jidc.6798.

  PMID: 27130993 BACKGROUND

• Abdelkader MM, Aboshanab KM, El-Ashry MA, Aboulwafa MM. Prevalence of MDR pathogens of bacterial meningitis in Egypt and new synergistic antibiotic combinations. PLoS One. 2017 Feb 16;12(2):e0171349. doi: 10.1371/journal.pone.0171349. eCollection 2017.

  PMID: 28207768 BACKGROUND

• Talaat M, El-Shokry M, El-Kholy J, Ismail G, Kotb S, Hafez S, Attia E, Lessa FC. National surveillance of health care-associated infections in Egypt: Developing a sustainable program in a resource-limited country. Am J Infect Control. 2016 Nov 1;44(11):1296-1301. doi: 10.1016/j.ajic.2016.04.212. Epub 2016 Jun 20.

  PMID: 27339791 BACKGROUND

• Hu HR. Fatal Vitamin K-Dependent Coagulopathy Associated with Cefoperazone/Sulbactam: A Case Report. Drug Saf Case Rep. 2019 Jun 14;6(1):6. doi: 10.1007/s40800-019-0100-0.

  PMID: 31201572 BACKGROUND

• Wang W, Liu Y, Yu C, Tan J, Xiong W, Dong D, Li S, Zhang R, Li J, Wu Y, Zong Z, Su N, Zou K, Wu G, Sun X. Cefoperazone-sulbactam and risk of coagulation disorders or bleeding: a retrospective cohort study. Expert Opin Drug Saf. 2020 Mar;19(3):339-347. doi: 10.1080/14740338.2020.1713090. Epub 2020 Jan 27.

  PMID: 31914329 BACKGROUND

• Park GH, Kim S, Kim MS, Yu YM, Kim GH, Lee JS, Lee E. The Association Between Cephalosporin and Hypoprothrombinemia: A Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Oct 16;16(20):3937. doi: 10.3390/ijerph16203937.

  PMID: 31623191 BACKGROUND

MeSH Terms

Conditions

Hemostatic Disorders

Interventions

Vitamin K

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: February 23, 2023
• Study Start: February 25, 2023
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

EG (1)