Effect of plasma volume expansion with hydroxy-ethyl-starch (HES) 130/0.4 or crystalloids on interstitial fluid accumulation and blood pressure in newborn infants with arterial hypotension

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002096-16-AT

Enrollment

Registered

2005-04-18

Start date

2005-05-23

Completion date

Unknown

Last updated

2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial hypotension

Interventions

Trade Name: Voluven Product Name: Voluven Pharmaceutical Form: Solution for infusion INN or Proposed INN: Hydroxy-Ethyl-Starch 130/0,4 Concentration unit: % percent Concentration type: equal Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Newborn infants with a postmenstrual age of less than 44 weeks and 2. Diagnosis of arterial hypotension Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Major congenital malformations (affecting the renal and cardio-vascular system) 2. Bleeding disorders 3. Renal failure with oliguria 4. Hypervolaemia with lung oedema

Design outcomes

Primary

Measure	Time frame
Main Objective: We investigate in newborns (e.g. term or preterm infants of less than 44 weeks postmenstrual age) with arterial hypotension, whether plasma volume expansion by HES 130/0.4 (Voluven) leads to less fluid loss into the interstitial space and increases the blood pressure more effectively and permanently than the administration of crystalloid solutions .;Secondary Objective: 1. Need for an additional volume substitution due to arterial hypotension; 2. Urinary output; 3. Requirement for catecholamines to maintain blood pressure above the nominal value of postmenstrual age; 4. Intravascular volume expansion (evaluated as a decrease in haematocrit and serum proteins after the administration of fluids); 5. Respiratory compliance (estimated in a subgroup of patients on mechanical ventilation) ;Primary end point(s): a) Success rate: correction of arterial blood pressure above the nominal value of postmenstrual age for at least 2 hours after intervention. b) Extravascular fluid accumulation: estimated during the 48 hours after the intervention, judged by i) positive fluid balance and/or oedema formation, characterized by an oedema index	—

Measure

Time frame

Main Objective: We investigate in newborns (e.g. term or preterm infants of less than 44 weeks postmenstrual age) with arterial hypotension, whether plasma volume expansion by HES 130/0.4 (Voluven) leads to less fluid loss into the interstitial space and increases the blood pressure more effectively and permanently than the administration of crystalloid solutions .;Secondary Objective: 1. Need for an additional volume substitution due to arterial hypotension; 2. Urinary output; 3. Requirement for catecholamines to maintain blood pressure above the nominal value of postmenstrual age; 4. Intravascular volume expansion (evaluated as a decrease in haematocrit and serum proteins after the administration of fluids); 5. Respiratory compliance (estimated in a subgroup of patients on mechanical ventilation) ;Primary end point(s): a) Success rate: correction of arterial blood pressure above the nominal value of postmenstrual age for at least 2 hours after intervention. b) Extravascular fluid accumulation: estimated during the 48 hours after the intervention, judged by i) positive fluid balance and/or oedema formation, characterized by an oedema index

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026