Unfractioned Heparin for Treatment of Sepsis

NCT00100308 | Completed Phase 3 DMC

• 1 other identifier: COLCIENCIAS -11150416347
• Study Type: interventional
• Target: 319
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether low dose continuous infusion of unfractioned heparin (500 units/hour), in addition to the standard treatment, is efficacious as complementary therapy for sepsis patients.

Conditions

Sepsis; Bacterial Infections

Keywords

sepsis; Randomized clinical trial; Heparin; Therapy

Outcome Measures

Primary Outcomes (2)

• Change from baseline Multiple Organ Dysfunction (MOD) score

  15 days

• Length of stay

  During hospitalization

Secondary Outcomes (1)

• 28-day all-cause mortality

  28 days

Study Arms (2)

1

EXPERIMENTAL

Standard treatment plus unfractioned heparin low-dose continuous infusion

Drug: Unfractioned heparin

2

PLACEBO COMPARATOR

Standard treatment plus placebo

Drug: saline

Interventions

Unfractioned heparin DRUG

Low-dose continuous-infusion, 500 units/hour per seven days

1

saline DRUG

Saline placebo

2

Eligibility Criteria

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

You may qualify if:

• Patients must have an infection defined by clinical and/or microbiological criteria in accordance with modified CDC definitions for nosocomial infections
• Patients must present with one or more of the GENERAL VARIABLES, AND one or more of the INFLAMMATORY VARIABLES within 24 hours before admission to the study
• GENERAL VARIABLES:
• Temperature (oral or axillary) \> 38ºC or \< 36ºC,
• Heart rate \> 90 beats/min,
• Respiratory rate \> 20 breaths/min,
• Altered mental status determined by Glasgow Coma Scale \< 15,
• Systolic blood pressure \< 90 mm Hg or a decrease \> 40 mm Hg
• INFLAMMATORY VARIABLES:
• WBC \> 12,000 μL-1 or \< 4,000 μL-1 or with \> 10% immature forms,
• Plasma C-reactive protein \> 5 mg/dL.
• These variables should not be attributable to an underlying disease other than infection or due to the effects of concomitant therapy.

You may not qualify if:

• Pregnant or breastfeeding.
• Platelet count \< 60,000/mm3.
• Increased risk for bleeding: \* Any patient who has undergone major surgery, defined as surgery that required general or spinal anesthesia, performed within the 12-hour period immediately preceding admission to the hospital; any postoperative patient who demonstrates evidence of active bleeding; or any patient with planned or anticipated major surgery during the first 12 hours after admission to the hospital. \* History of: severe head trauma that required hospitalization, intracranial surgery, or stroke within 3 months of study entry; or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesion. \* History of congenital bleeding diatheses, such as hemophilia. \* Gastrointestinal bleeding within 6 weeks of study entry that required medical intervention unless definitive surgery has been performed. \* Trauma patients at increased risk of bleeding, for example: flail chest; significant contusion to lung, liver, or spleen; retroperitoneal bleed; pelvic fracture; or compartment syndrome.
• Patients with a known hypercoagulable condition including activated Protein C resistance; a hereditary deficiency of Protein C, Protein S, or antithrombin; presence of anticardiolipin antibody, antiphospholipid syndrome, lupus anticoagulant or homocysteinemia; or patients with a recently documented (within 3 months of study entry) or highly suspected deep venous thrombosis or pulmonary embolism.
• Patients taking or requiring the following medications: \* Therapeutic heparin, defined as UFH dosed to treat an active thrombotic or embolic event within the 12 hours prior to study entry or LMWH used at any dose higher or more frequent than the recommended dose on the product label for prophylaxis within the 12 hours prior to study entry. \* Warfarin, if used within 7 days of study entry. \* Thrombolytic treatment within 3 days of study entry (for example, streptokinase, rtPA, and urokinase). \* Glycoprotein IIb/IIIa antagonists within 7 days of study entry.
• Patients with known esophageal varices, chronic jaundice, cirrhosis, or chronic ascites.
• Patients not expected to survive 28 days given their preexisting, uncorrectable medical condition. This criterion includes patients with, or suspected to have, poorly controlled neoplasms or other end-stage processes, such as end-stage cardiac disease, prior cardiac arrest, end-stage lung disease, or end-stage liver disease.
• Patients with chronic renal failure on either hemodialysis or peritoneal dialysis.
• HIV positive patients with most recent CD4 count \< 200/mm3.
• Patients who have undergone bone marrow, liver, lung, kidney or pancreas transplantation.
• Inability or unwillingness of patients or legal representative to give written informed consent.

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator

Study Sites (1)

Hospital Universitario San Vicente de Paul

Medellín, Antioquia, Colombia

Location

MeSH Terms

Conditions

Sepsis; Bacterial Infections

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fabián A Jaimes, MD, MSc, PhD

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 28, 2004
• First Posted: December 29, 2004
• Study Start: July 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: January 15, 2008

Record last verified: 2008-01

Locations

CO (1)