Impact of Amount of Fluid for Circulatory Resuscitation on Renal Function in Patients in Shock

NCT02666404 | Terminated DMC

• 1 other identifier: EKNZ 2015-401
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

Volume resuscitation is the mainstay of treatment in most types of shock, especially in hemorrhagic and septic shock. Septic shock is a main cause of morbidity and mortality worldwide. Although there has been a lot of research to evaluate optimal amount and composition of fluids for volume resuscitation (e.g. colloids, crystalloids, red blood cell transfusion, albumin, fresh frozen plasma) particularly in the past decade, results remain inconclusive and to some extent contradictive. The investigators would like to contribute to the establishment of new endpoints for the guidance of shock therapy focusing on the first 24 and 48 hours, amending the currently used parameters (i.e. cardiac output, heart rate, blood pressure, central venous pressure) with new measurements (see study specific measurements). The goal is to decrease the need for renal replacement therapy, thereby eventually reducing patient morbidity and mortality.

Conditions

Shock

Keywords

Volume Resuscitation; Shock; Body Impedance Measurement; Renal Resistive Index; Acute Kidney Injury; Renal Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury (KDIGO staging for severity of acute kidney injury ).

  Change in renal function from baseline according to KDIGO staging

  Assessment at 0, 6, 24, 48, and 72 hours after shock diagnosis

Secondary Outcomes (6)

• Difference in lactate values (µmol/l)

  Between 6 and 24 hours after admittance to the ICU and baseline (t1/t2 - t0)

• Need for renal replacement therapy (KDIGO staging for severity of acute kidney injury)

  Assessment at 0, 6, 24, 48, and 72 hours after shock diagnosis

• Length of ICU stay

  1 month

• Length of hospital stay

  1 month

• Need for mechanical ventilation

  During 27 hours

Study Arms (1)

Volume Resuscitation

EXPERIMENTAL

We would like to establish new endpoints for guidance of volume resuscitation by implementing new measurements (body impedance, renal resistive index).

Other: Measurement

Interventions

Measurement OTHER

We will perform those new measurements and assessments for guidance of fluid resuscitation at 0, 6, 24, 48, and 72 hours after shock diagnosis and concomitant fulfillment of eligibility requirements

Also known as: Body Impedance Measurement, Renal Resistive Index, Intra-abdominal Pressure

Volume Resuscitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• State of shock (any type) upon admittance to the ICU.

You may not qualify if:

• Age below 18 years
• Non-shock state
• Terminal state
• Pregnancy
• Jehovah's Witnesses

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Shock; Acute Kidney Injury

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Martin Siegemund, MD

  Deputy Chief Physician, Surgical Intensive Care Unit

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 28, 2016
• Study Start: January 1, 2016
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)