Terminated PHASE4 INTERVENTIONAL 2-arm NCT02715466

Gelatin in ICU and Sepsis (GENIUS)

Prospective, Controlled, Double-Blind, Randomized Multicentric Study On The Efficacy And Safety Of An Early Target Controlled Plasma Volume Replacement Therapy With A Balanced Gelatine Solution vs A Balanced Electrolyte Solution In Patients With Severe Sepsis

Sponsor: B. Braun Melsungen AG

Conditions Hypovolemia

Interventions Balanced electrolyte solution Balanced gelatine solution

Updated 14 times since 2017 Last updated: Aug 5, 2025 Started: Apr 30, 2016 Primary completion: Dec 8, 2021 Completion: Dec 8, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

recommended by DSMB

Other terminated trials from B. Braun Melsungen AG

More terminations from B. Braun Melsungen AG

A PHASE4 clinical study on Hypovolemia, this trial is terminated or withdrawn. The trial is conducted by B. Braun Melsungen AG and has accumulated 14 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

14 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE4
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE4
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE4
Jun 2022 — Jul 2024 [monthly]

Terminated PHASE4

Status: Recruiting → Terminated
Oct 2021 — Jun 2022 [monthly]

Recruiting PHASE4

▶ Show 9 earlier versions

Jun 2021 — Oct 2021 [monthly]

Recruiting PHASE4
Jan 2021 — Jun 2021 [monthly]

Recruiting PHASE4
Feb 2020 — Jan 2021 [monthly]

Recruiting PHASE4
Jan 2020 — Feb 2020 [monthly]

Recruiting PHASE4
Mar 2019 — Jan 2020 [monthly]

Recruiting PHASE4
Sep 2018 — Mar 2019 [monthly]

Recruiting PHASE4
Jun 2018 — Sep 2018 [monthly]

Recruiting PHASE4
Sep 2017 — Jun 2018 [monthly]

Recruiting PHASE4
Jan 2017 — Sep 2017 [monthly]

Recruiting PHASE4

First recorded

Apr 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

B. Braun Melsungen AG

Data source: B. Braun Melsungen AG

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aachen, Germany , Barcelona, Spain , Bremen, Germany , Frankfurt am Main, Germany , Innsbruck, Austria , Madrid, Spain , Minden, Germany , Nantes, France , Nice, France , Rostock, Germany and 2 more locations