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Safety and Efficacy of Lean Body Weight-based IV Heparin Dosing in Obese/Morbidly Obese Patients

NCT01363193 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-05-14

No results posted yet for this study

Summary

Standard weight-based IV heparin for normal weight patients is based on actual body weight (ABW). However, no well-defined guidelines have been established for patients considered to be obese or morbidly obese. In current practice, the calculated ABW based heparin initial bolus dose and infusion rates are quite high, and therefore often not used for obese/morbidly obese patients for fear of bleeding.

Heparin is distributed in the body approximately the same as blood and does not get distributed to adipose tissue. There are some studies suggesting that lean body weight (LBW) might be a better basis for dosing heparin. LBW is a calculated weight that excludes the weight of fat.

The investigators hypothesize that intravenous heparin dosing based on the Lean body weight of obese/morbidly obese patients would be safe and effective in achieving a therapeutic level of heparin in 24 hours compared to the usual practice in this patient population.

Conditions

Interventions

DRUG

Lean Body Weight-based heparin dose

For patients who meet the inclusion criteria including body mass index of 30 and greater (and do not have any exclusion criteria), will have intravenous weight-based heparin (unfractionated heparin) dose based on their Lean body weight. Lean Body Weight is based on the formula by Janmahasatian et al. 2005. Calculated by a computer program; Male = \[9270 x weight (kg)\] / \[6680+216 x BMI\] Female = \[9270 x weight (kg)\] / \[8780+244 x BMI\]

Sponsors & Collaborators

  • Nazareth Hospital

    lead OTHER

Principal Investigators

  • Rachel J Park, PharmD, BCPS · Nazareh Hospital - Mercy Health System

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01363193 on ClinicalTrials.gov