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Completed

NCT Number: NCT00811109

HEMOTOL: Efficacy and Safety of Hemodialysis On-line Monitoring Devices on Hemodynamic Stability in Intensive Care Unit

The purpose of this randomized controlled study is to compare the effects of different new dialysis on-line monitoring devices on hemodynamic stability during intermittent hemodialysis in critically ill patients with acute kidney injury.

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Key information

Conditions

Hemodialysis Acute Kidney Injury Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypotension Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Service de Réanimation Médicale - CHU de Caen

Caen, 14000, France

About this study

Acute kidney injury (AKI) is associated with high mortality and morbidity rates in critically ill patients despite advances in renal replacement therapy (RRT). Over the last few years, new devices in dialysis equipment, such as blood temperature and blood volume on-line monitors, have been developed to improve hemodynamic tolerance, and these new modalities have demonstrated their positive impact on decrease in intra-dialytic hypotension rate in chronic hemodialysis patients. In order to evaluate these new devices in critically ill patients with acute kidney injury we decided to conduct a prospective randomized controlled trial.

We based calculation of the sample size on a power analysis that assumed an expected decrease in intra-dialytic hypotension rate of 40% (from a crude intra-dialytic hypotension rate of 30% to 18%) in groups B and C, compared with group A. Analysis is done by intention to treat, according to prescribed new dialysis on-line monitoring devices.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years
  • Acute Kidney injury requiring intermittent hemodialysis

Exclusion criteria

  • Age < 18 years
  • End-stage renal failure
  • Inclusion in other protocol
  • Absence of consent

Treatment and study plan

standard hemodialysis

Device

Gold standard bicarbonate hemodialysis therapy with constant ultrafiltration rate and dialysis conductivity performed with Fresenius 4008S monitor (Fresenius Medical Care, France)

Other names: Treatment A

with Blood Volume Management (BVM®) only

Device

Hemodialysis using Blood Volume on-line monitoring only. Hemodialysis will be performed with Fresenius 4008S monitor (Fresenius Medical Care, France) equipped with BVM® device (for blood volume monitor; Fresenius Medical Care, France)

Other names: Treatment B

with Blood Volume (BVM®) and Temperature (BTM®) on-line monitoring

Device

Hemodialysis using Blood volume and Blood temperature on-line monitoring. Hemodialysis will be performed with Fresenius 4008S monitor (Fresenius Medical Care, France) equipped with BVM® and BTM® devices (for blood volume monitor and blood temperature management, respectively; Fresenius Medical Care, France)

Other names: Treatment C

Primary outcomes

  1. Intra-Dialytic Hypotension

    Time frame: 60 days

Secondary outcomes

  1. Compliance to treatment; intra-dialytic complications; dialysis dose; blood temperature control; blood volume control

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

HEMOTOL: Effects of New Dialysis On-line Monitoring Devices on Hemodynamic Stability During Intermittent Hemodialysis in Critically Ill Patients With Acute Kidney Injury : a Prospective Randomized Study.

Acronym: HEMOTOL

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 18, 2008
Registry last updated
Mar 3, 2010

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.

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