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Respiratory Alterations of Acid-base Equilibrium: Acute and Chronic Renal Response

Respiratory Alterations of Acid-base Equilibrium: Acute and Chronic Renal Response

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01540916
Enrollment
50
Registered
2012-02-29
Start date
2012-02-29
Completion date
2015-11-30
Last updated
2015-11-10

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

Conditions

Acute Respiratory Variations of Acid-base Equilibrium

Keywords

acid-base equilibrium, renal system, urinary electrolytes

Brief summary

Alterations of acid-base equilibrium are very common in critically ill patients. Thus, understanding their pathophysiology and the possible compensatory mechanisms acting in different organs may play an important role in better set the consequent clinical treatment. The lung and the kidney are the two principal actors of such regulations. Although the respiratory response to acid-base alterations is well understood, less information are available for what the renal system is concerned. Such lack of information is partially due to: 1) the historical consideration of the kidney as a slow organ, in response to variations in acid-base equilibrium; 2) the lack of a monitoring system to closely assess renal response. Our group has recently developed a monitoring system aimed at analyzing, in a quasi-continuous and non-invasive manner (every 10 min) the urinary profile in terms of urinary pH and electrolyte concentrations (sodium, potassium, chloride, ammonium). The investigators hypothesize that the renal system reacts to large as well as to minimal variations of the acid-base equilibrium (especially induced by a variation in the respiratory function) in a very fast way, modifying the urinary concentration (and therefore the urinary excretion) of ammonium and some electrolytes (especially chloride).

Detailed description

Primary aim: To investigate the acute renal response to respiratory alterations of acid-base equilibrium in order to better understand the underlying physiological mechanisms and to evaluate the validity of a renal monitoring system to indirectly assess the effectiveness of the respiratory function. Secondary aim: To collect data on the chronic response of the renal system in patients affected by chronic obstructive pulmonary disease (COPD), as well as on the acute response to acute variation of the chronic respiratory acidosis characterizing patients affected by COPD exacerbation. Study protol: Mechanically ventilated patients will undergo controlled variation of the ventilatory setting (hyperventilation vs. hypoventilation) in order to induce a controlled reduction or increase in arterial partial pressure of carbon dioxide (and an increase or reduction of arterial pH), within normal range of pH (7.35 - 7.45) During the variations, urinary concentrations of electrolytes and pH will be monitored.

Interventions

OTHERIncrease minute ventilation

Respiratory rate will be increase in order to have a 30% increase of minute ventilation

OTHERDecrease minute ventilation

Respiratory rate will be decrease in order to have a 30% decrease of minute ventilation

Sponsors

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Presence of mechanical ventilation 2. Presence of arterial and central venous line 3. Presence of urinary catheter

Exclusion criteria

1. acute or chronic renal failure with anuria 2. presence of continuous renal replacement therapy 3. hemodynamic instability 4. less than 16 years of age

Design outcomes

Primary

MeasureTime frame
Variations in urinary electrolyte concentrations and pHFrom 0 to 4 hours

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026