NCT03220620

Brief Summary

The objective of the study is to evaluate influence of perioperative fluid therapy on Methemoglobin levels, and to changes in hemoglobin. Further, changes in Methemoglobin will be related to metabolic signs of oxidative stress (changes in blood lactate). Patients undergoing major abdominal surgery will be included into the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 14, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

July 14, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2.5 years

First QC Date

July 14, 2017

Last Update Submit

November 2, 2020

Conditions

Perioperative/Postoperative ComplicationsFluid OverloadHemoglobin H

Keywords

fluid therapyperioperativehemodilution

Outcome Measures

Primary Outcomes (2)

  • Influence of perioperative fluid therapy on hemoglobin levels

    Influence of perioperative fluid therapy on hemoglobin levels

    during surgery

  • Influence of perioperative fluid therapy on Methemoglobin levels

    Influence of perioperative fluid therapy on Methemoglobin levels

    during surgery

Secondary Outcomes (2)

  • Influence of perioperative fluid therapy on changes in lactate

    during surgery

  • Influence of perioperative fluid therapy on SvO2

    during surgery

Study Arms (2)

GDT Group

receives goal-directed therapy

Other: GDT

Not GDT Group

receives no individualized goal-directed therapy

Interventions

GDTOTHER

individualized fluid therapy

GDT Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing major abdominal surgery

You may qualify if:

  • major abdominal surgery
  • informed consent

You may not qualify if:

  • violation of study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

Location

MeSH Terms

Conditions

Postoperative ComplicationsEdema

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Thomas Mencke, Prof.

    University of Rostock

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 18, 2017

Study Start

July 14, 2017

Primary Completion

December 31, 2019

Study Completion

January 1, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)