NCT02962700

Brief Summary

The aim of the study was to investigate whether CVVH, in comparison to intermittent haemodialysis (IHD), is able to improve regional perfusion in septic shock patients studied by muscle microdialysis

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

November 4, 2016

Last Update Submit

November 10, 2016

Conditions

Septic Shock

Keywords

continuous haemofiltrationintermittent haemodialysis

Outcome Measures

Primary Outcomes (4)

  • changes in the concentration of glucose (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle.

    at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

  • changes in the concentration of lactate (mmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle

    at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

  • changes in the concentration of pyruvate (µmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle

    at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

  • changes in the concentration of glycerol (µmol/l) in the extracellular fluid of the skeletal muscle using a microdialysis probe inserted into the quadriceps femoris muscle

    at baseline, 6, 12,18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

Secondary Outcomes (3)

  • changes in mean arterial blood pressure

    at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

  • changes in heart rate

    at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

  • changes in vasopressor support doses

    at baseline, 6, 12, 18, 24, 30, 36, 42 and 48 hours after initiation of renal replacement

Study Arms (2)

CVVHF

EXPERIMENTAL

CVVHF for 48 h interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.

Device: muscle microdialysis

IHD for 4 hours

ACTIVE COMPARATOR

Intermittent haemodialysis was carried out during the first 4 h at day 1 and day 2 of the study period. Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.

Device: muscle microdialysis

Interventions

muscle microdialysisDEVICE

Systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.

CVVHFIHD for 4 hours

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • septic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Military Hopital of Tunis

Tunis, 1008, Tunisia

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • mustapha ferhjani

    Department of C ritical C are Medicine and Anesthesiology, Military Hospital of Tunis, Tunisia, Tunis, Tunisia

    STUDY DIRECTOR

Central Study Contacts

zied hajjej

CONTACT

20358907hajjej_zied@hotmail.com

mustapha ferjani

CONTACT

98329256mustapha.ferjani@planet.tn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 4, 2016

First Posted

November 11, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

November 11, 2016

Record last verified: 2016-11

Locations

TU(1)