ORal antibiotics In Acute Mesenteric Ischemia: a multicenter randomized

Conditions

Acute mesenteric ischemia

Brief summary

Occurrence of intestinal necrosis or death within 30 days following randomisation defined by the following criteria histology assessment OR all-cause mortality within 30 days following randomisation

Detailed description

Oral antibiotics impact assessment endpoints a. occurrence of intestinal necrosis within the 30 days following the randomisation. b. vital status at day-30 after the randomisation c. short bowel syndrome at day-30 after the randomisation d. total length of intestinal resection at day 30 following the randomisation e. occurrence of organ failure within the 30 days following the randomisation f. number of days in the intensive care unit g. number of hospitalization days, Safety endpoints a. Occurrence of minor side effects b. Occurrence of hypersensitivity reaction to antibiotics c. Occurrence of other adverse events d. Emergence of antimicrobial-resistant microorganisms e. Occurrence of healthcare-associated infection, Antibiotics’ pharmacokinetic and blood concentration endpoints: a. Blood levels of gentamicin at randomisation day , days 7 and 14 after randomisation b. Blood levels of metronidazole at randomisation day, days 7 and 14 after randomisation

Related papers

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Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGGENTAMICINE PANPHARMA 80 mg

DRUGsolution injectable

DRUGMetronidazole Biogaran 500 mg Placebo

DRUGGentamicin Placebo

DRUGNatriumchlorid-Lösung 0

DRUG9 % Deltamedica

DRUGInjektionslösung

DRUGMETRONIDAZOLE BIOGARAN 500 mg

DRUGcomprimé pelliculé

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of intestinal necrosis or death within 30 days following randomisation defined by the following criteria histology assessment OR all-cause mortality within 30 days following randomisation	—

Secondary

Measure	Time frame
Oral antibiotics impact assessment endpoints a. occurrence of intestinal necrosis within the 30 days following the randomisation. b. vital status at day-30 after the randomisation c. short bowel syndrome at day-30 after the randomisation d. total length of intestinal resection at day 30 following the randomisation e. occurrence of organ failure within the 30 days following the randomisation f. number of days in the intensive care unit g. number of hospitalization days, Safety endpoints a. Occurrence of minor side effects b. Occurrence of hypersensitivity reaction to antibiotics c. Occurrence of other adverse events d. Emergence of antimicrobial-resistant microorganisms e. Occurrence of healthcare-associated infection, Antibiotics’ pharmacokinetic and blood concentration endpoints: a. Blood levels of gentamicin at randomisation day , days 7 and 14 after randomisation b. Blood levels of metronidazole at randomisation day, days 7 and 14 after randomisation	—

Measure

Time frame

Oral antibiotics impact assessment endpoints a. occurrence of intestinal necrosis within the 30 days following the randomisation. b. vital status at day-30 after the randomisation c. short bowel syndrome at day-30 after the randomisation d. total length of intestinal resection at day 30 following the randomisation e. occurrence of organ failure within the 30 days following the randomisation f. number of days in the intensive care unit g. number of hospitalization days, Safety endpoints a. Occurrence of minor side effects b. Occurrence of hypersensitivity reaction to antibiotics c. Occurrence of other adverse events d. Emergence of antimicrobial-resistant microorganisms e. Occurrence of healthcare-associated infection, Antibiotics’ pharmacokinetic and blood concentration endpoints: a. Blood levels of gentamicin at randomisation day , days 7 and 14 after randomisation b. Blood levels of metronidazole at randomisation day, days 7 and 14 after randomisation

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Countries

France

Outcome results

None listed