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The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients

NCT ID: NCT03590873

Last Updated: 2018-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-25

Study Completion Date

2019-06-04

Brief Summary

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This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loos during burn surgery.

Detailed Description

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This is a randomized double-blinded study to investigate the effect of fluid restriction and vasopressin on blood loss during surgery of the burn patients. The groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loss during the surgery.

Conditions

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Burn Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control group

Intraoperative fluid management: administration of 6-10 ml/kg/hr of crystalloid solution.

Group Type NO_INTERVENTION

No interventions assigned to this group

Restrictive group

Intervention: administration of vasopressin 0.01 - 0.04 U/min after induction of anesthesia.

Intraoperative fluid management: administration of 2-4 ml/kg/hr of crystalloid solution.

Group Type EXPERIMENTAL

Vasopressin

Intervention Type DRUG

Vasopressin, is a hormone synthesized as a peptide prohormone in neurons in the hypothalamus, and is converted to arginine vasopressin. It then travels down the axon of that cell, which terminates in the posterior pituitary, and is released from vesicles into the circulation in response to extracellular fluid hypertonicity (hyperosmolality). Arginine vasopressin has two primary functions. First, it increases the amount of solute-free water reabsorbed back into the circulation from the filtrate in the kidney tubules of the nephrons. Second, arginine vasopressin constricts arterioles, which increases peripheral vascular resistance and raises arterial blood pressure.

Interventions

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Vasopressin

Vasopressin, is a hormone synthesized as a peptide prohormone in neurons in the hypothalamus, and is converted to arginine vasopressin. It then travels down the axon of that cell, which terminates in the posterior pituitary, and is released from vesicles into the circulation in response to extracellular fluid hypertonicity (hyperosmolality). Arginine vasopressin has two primary functions. First, it increases the amount of solute-free water reabsorbed back into the circulation from the filtrate in the kidney tubules of the nephrons. Second, arginine vasopressin constricts arterioles, which increases peripheral vascular resistance and raises arterial blood pressure.

Intervention Type DRUG

Other Intervention Names

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Antidiuretic hormone, arginine vasopressin, or argipressin

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years old
* burn patients undergoing surgery (TBSA \> 20%)

Exclusion Criteria

* age \< 18 years old
* history of renal disorder
* history of cardiac disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role collaborator

Hangang Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee Yeong Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Kug Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Hangang Sacred Heart Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee Yeong Kim, MD

Role: CONTACT

Phone: 82226395650

Email: [email protected]

Facility Contacts

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Hee Yeong Kim, MD

Role: primary

Other Identifiers

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2018-051

Identifier Type: -

Identifier Source: org_study_id