NCT02993640

Brief Summary

The purpose of this study is to determine if vasopressin and nitroglycerin in combination will affect hepatic hemodynamics, in the setting of liver surgery.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Sep 2016

Shorter than P25 for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2017

Completed
Last Updated

November 8, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

December 12, 2016

Last Update Submit

November 6, 2018

Conditions

Portal Blood PressureLiver SurgeryHepatic Hemodynamics

Keywords

vasopressinnitroglycerineportal pressureportal flow

Outcome Measures

Primary Outcomes (2)

  • Portal and hepatic venous flow after vasopressin and nitroglycerine infusion

    six - nine months

  • Pressure in the hepatic and portal veins after vasopressin and nitrovasopressin infusion

    six - nine months

Secondary Outcomes (1)

  • lactate in the splanchnic circulation

    six-nine months

Study Arms (1)

vasopressin + nitro

EXPERIMENTAL

vasopressin + nitroglycerin in simultaneous infusion

Drug: vasopressin + nitro

Interventions

vasopressin + nitroDRUG

vasopressin infusion 4,8 U/h for 20 minutes, thereafter nitroglycerine infusion to a MAP of 60 for 5 minutes.

vasopressin + nitro

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients within ASA-class I-II scheduled for open liver resection

You may not qualify if:

  • ASA-class III and IV, more than 2 medications for hypertension, BMI \> 35, technical difficulties with insertion av catheters, extensive surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wisen E, Svennerholm K, Bown LS, Houltz E, Rizell M, Lundin S, Ricksten SE. Vasopressin and nitroglycerin decrease portal and hepatic venous pressure and hepato-splanchnic blood flow. Acta Anaesthesiol Scand. 2018 Aug;62(7):953-961. doi: 10.1111/aas.13117. Epub 2018 Mar 26.

    PMID: 29578250DERIVED

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

Vasopressins

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Sven-Erik Ricksten, Professor

    Sahlgrenska University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 15, 2016

Study Start

September 1, 2016

Primary Completion

March 20, 2017

Study Completion

March 20, 2017

Last Updated

November 8, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

No plans of sharing IPD