Skip to main content
OpenTrials
Completed

NCT Number: NCT03220620

Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Perioperative/Postoperative Complications Edema Fluid Overload Hemoglobin H Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rostock

Rostock, Mecklenburg-Vorpommern, 18057, Germany

About this study

Increasing plasma volume by intravenous administration of crystalloid and/or colloid solutions may cause a relative reduction in hemoglobin (Hb) concentration, a situation that is termed 'dilutional anemia'. Such hemodilution may lead to an iatrogenic reduction in oxygen-carrying capacity and the development of organ dysfunction. Paradoxically, large amounts of fluids that are administered with the aim of increasing oxygen delivery (DO2), as is frequently done as part of perioperative goal-directed therapy; this may lead to an actual decrease in the DO2 due to a decrease in Hb concentration.

Another potential parameter that may reflect the development of dilutional anemia is methemoglobin (MetHb), a form of Hb with reduced ability for oxygen binding. Experimental studies showed that dilutional anemia may lead to up-regulation of perivascular nitric oxide synthase (NOS) and increase NOS-derived nitric oxide (NO) leading to local vasodilation and oxidization of Hb to MetHb. MetHb may potentially serve as a biomarker of 'anemic stress' associated with reduced tissue perfusion during acute hemodilution.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • major abdominal surgery
  • informed consent

Exclusion criteria

  • violation of study protocol

Treatment and study plan

GDT

Other

individualized fluid therapy

Primary outcomes

  1. Influence of perioperative fluid therapy on hemoglobin levels

    Time frame: during surgery

    Influence of perioperative fluid therapy on hemoglobin levels

  2. Influence of perioperative fluid therapy on Methemoglobin levels

    Time frame: during surgery

    Influence of perioperative fluid therapy on Methemoglobin levels

Secondary outcomes

  1. Influence of perioperative fluid therapy on changes in lactate

    Time frame: during surgery

    Influence of perioperative fluid therapy on changes in lactate

  2. Influence of perioperative fluid therapy on SvO2

    Time frame: during surgery

    Influence of perioperative fluid therapy on SvO2

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

Influence of Perioperative Fluid Therapy on Hemoglobin and Methemoglobin Levels in Major Abdominal Surgery

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 18, 2017
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.